Synthetic Vasomotion for Glymphatic Enhancement

September 5, 2026 updated by: Florida Institute for Human and Machine Cognition

Synthetic Vasomotion for Glymphatic Enhancement: A Pilot Study of Intermittent Hypercapniaand Noninvasive Vagus Nerve Stimulation With Continuous Parenchymal Resistance Monitoring inParkinson's Disease and Healthy Older Adults

The goal of this pilot clinical trial is to learn whether a week-long study combining controlled breathing procedures, intermittent exposure to a low-concentration carbon dioxide gas mixture, and noninvasive vagus nerve stimulation can be carried out safely and comfortably in adults with early-stage Parkinson's disease and age-matched healthy adults. The study will also explore how these procedures affect physiological signals related to breathing, cardiovascular and autonomic function, brain activity, and physiological processes thought to be related to fluid movement in and around the brain.

The main questions the study aims to answer are:

  • Can participants safely and comfortably complete the study procedures and at-home monitoring?
  • Do physiological responses differ when intermittent hypercapnia is paired with active noninvasive vagus nerve stimulation compared with sham stimulation?
  • Are changes measured during the intervention visits related to overnight physiological measurements and changes in blood-based biomarkers?

Researchers will compare active and sham noninvasive vagus nerve stimulation within the same participants. Both conditions will be paired with guided breathing and intermittent hypercapnia, in which participants briefly breathe a controlled gas mixture containing 5% carbon dioxide.

Participants will:

  • Complete an intake and baseline visit and several nights of at-home physiological monitoring.
  • Complete two intervention visits in randomized order, one using active vagus nerve stimulation and one using sham stimulation.
  • Complete guided breathing and intermittent hypercapnia procedures while respiratory, cardiovascular, and other physiological signals are monitored.
  • Provide blood samples before and after intervention procedures for exploratory biomarker measurements.

This is an exploratory pilot study. It is not intended to diagnose, treat, or prevent Parkinson's disease or any other medical condition.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This pilot study will evaluate the feasibility, safety, tolerability, and exploratory physiological effects of a multimodal intervention designed to influence autonomic, cerebrovascular, respiratory, and glymphatic-associated physiology. The study combines guided breathing, intermittent hypercapnia, and noninvasive vagus nerve stimulation (nVNS) with continuous or repeated physiological monitoring and exploratory blood-based biomarker assessment.

The glymphatic system is a brain-wide pathway involved in the exchange of cerebrospinal fluid and interstitial fluid and in the movement of metabolic waste products from brain tissue. Glymphatic-associated fluid transport is influenced by sleep, cerebrovascular pulsatility, vasomotion, respiratory physiology, and autonomic regulation. Parkinson's disease is associated with abnormalities in several of these systems, including autonomic function, sleep, and brainstem noradrenergic signaling. This study therefore examines whether controlled manipulation of respiratory and autonomic physiology produces measurable changes in physiological signals hypothesized to be relevant to glymphatic-associated fluid dynamics.

The study will enroll up to 20 adults, including approximately 10 participants with early-stage Parkinson's disease and 10 age-matched healthy control participants. The target analytic sample is approximately 16 participants after accounting for attrition, incomplete visits, or unusable data. The study is designed as a pilot and is not powered to establish clinical efficacy.

Participants will complete a week-long protocol. Following screening and informed consent, participants will complete an intake and baseline visit that may include health and demographic questionnaires, vital signs, baseline physiological measurements, guided breathing, and training on the Applied Cognition GF Monitor. Participants will then complete overnight at-home monitoring on two baseline nights.

Participants will subsequently complete two in-clinic intervention visits separated by approximately 48 hours. The order of active and sham nVNS will be randomized, and each participant will receive both conditions in a within-participant crossover design. During both intervention visits, nVNS or sham stimulation will be paired with guided breathing and intermittent hypercapnia. For intermittent hypercapnia, participants will breathe through a noninvasive mask connected to a controlled breathing circuit that alternates room air with a gas mixture containing approximately 5% carbon dioxide, 21% oxygen, and balance nitrogen. The hypercapnia procedure consists of three approximately 10-minute exposure blocks according to the study protocol. Respiratory and physiological measures will be monitored throughout the intervention and recovery periods, and participants may pause or discontinue procedures at any time.

Noninvasive vagus nerve stimulation will be delivered with the gammaCore device. In the active condition, stimulation will be applied to the cervical vagus nerve at a participant-tolerated intensity. In the sham condition, participants will undergo an otherwise similar procedure using a sham device that does not deliver the active electrical stimulation.

Physiological measurements may include transcutaneous or end-tidal carbon dioxide, oxygen saturation, respiratory timing and ventilation, heart rate, heart rate variability-related measures, blood pressure, electroencephalography, photoplethysmography, impedance-based physiological measures, and movement. The Applied Cognition GF Monitor will be used during in-clinic and at-home monitoring to collect multimodal physiological signals, including electrical impedance spectroscopy measurements used to estimate changes in brain parenchymal resistance. Overnight monitoring will also be performed after the first intervention visit to explore whether intervention-associated physiological changes persist into subsequent sleep.

Serial blood samples will be collected around the intervention procedures for exploratory measurement of plasma biomarkers associated with neurodegenerative, neuroinflammatory, and glymphatic-related physiological processes. Planned exploratory biomarkers include alpha-synuclein, neurofilament light chain, glial fibrillary acidic protein, amyloid-beta 1-42, amyloid-beta 1-40, and phosphorylated tau 217.

The primary emphasis of the study is feasibility, safety, tolerability, participant adherence, and successful physiological signal acquisition. Exploratory analyses will compare physiological responses during active nVNS plus intermittent hypercapnia with responses during sham nVNS plus intermittent hypercapnia. Additional exploratory analyses will examine relationships among in-clinic physiological responses, overnight monitoring measures, blood-based biomarker changes, and participant group. The results are intended to provide preliminary effect-size and variance estimates, identify practical and physiological response patterns, and inform the design and parameter selection of future hypothesis-driven trials.

This study is non-therapeutic and exploratory. It is not designed to establish clinical benefit or to diagnose, treat, or prevent Parkinson's disease or another medical condition.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Melissa Do, PhD
  • Phone Number: 850-202-4462
  • Email: mdo@ihmc.org

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

Parkinson's Disease Group

Adults aged 60-80 years at the time of enrollment. Clinical diagnosis of early-stage Parkinson's disease and not currently receiving levodopa or other dopaminergic medication.

Hoehn and Yahr stage I. English-speaking and able to provide informed consent and complete study procedures and questionnaires administered in English.

Cognitively able to participate in study procedures, as determined by investigator assessment and/or optional cognitive screening measures, when administered.

Willing and able to comply with all study visits and procedures. Able to tolerate wearing the Applied Cognition GF Monitor, physiological monitoring equipment, face mask, and noninvasive vagus nerve stimulation (nVNS) device for the duration of study procedures.

Age-Matched Healthy Control Group

Adults aged 60-80 years at the time of enrollment. No known diagnosis of Parkinson's disease or other major neurodegenerative disorder.

English-speaking and able to provide informed consent and complete study procedures and questionnaires administered in English.

Cognitively able to participate in study procedures, as determined by investigator assessment and/or optional cognitive screening measures, when administered.

Willing and able to comply with all study visits and procedures. Able to tolerate wearing the Applied Cognition GF Monitor, physiological monitoring equipment, face mask, and noninvasive vagus nerve stimulation (nVNS) device for the duration of study procedures.

Exclusion Criteria

Diagnosis of moderate-to-severe neurocognitive impairment or dementia. Significant pulmonary disease, including chronic obstructive pulmonary disease (COPD), severe asthma requiring daily rescue therapy, restrictive lung disease, or resting oxygen saturation <92%.

Untreated or poorly controlled hypertension, defined as systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg at screening.

Symptomatic hypotension, orthostatic hypotension associated with syncope, or clinically significant autonomic dysfunction.

Peripheral vascular disease, significant upper-extremity injury, or other conditions that may interfere with peripheral perfusion or physiological monitoring measurements.

Uncontrolled diabetes mellitus or diabetes-associated complications that may significantly affect autonomic or vascular physiology.

History of significant cardiac disease, including clinically significant arrhythmia, congestive heart failure, unstable angina, myocardial infarction within the prior 12 months, or other conditions judged unsafe for intermittent hypercapnia exposure.

Active implanted electrical or neurostimulation devices, including cardiac pacemakers, implantable cardioverter-defibrillators (ICDs), deep brain stimulators, cochlear implants, or implanted vagus nerve stimulators.

Active carotid artery disease, carotid bruits, history of carotid endarterectomy, or other clinically significant cervical vascular abnormalities that may increase risk during cervical nVNS application.

History of moderate or severe traumatic brain injury, defined as loss of consciousness >30 minutes or post-traumatic amnesia >24 hours.

Active psychiatric condition requiring hospitalization within the prior 12 months.

Current use of medications known to substantially alter cerebrovascular reactivity or carbon dioxide sensitivity, such as acetazolamide or other carbonic anhydrase inhibitors.

Claustrophobia or inability to tolerate mask-based breathing procedures. Pregnancy, suspected pregnancy, or lactation in participants of childbearing potential.

Body mass index (BMI) >40 kg/m² due to potential effects on respiratory physiology, mask fit, and CO₂ tolerance.

Known allergy or sensitivity to latex, adhesives, electrode gels, medical tapes, or study device materials that may interfere with safe participation.

Current acute respiratory infection or other acute illness at the time of study participation.

Any other medical, neurological, psychiatric, or safety-related condition that, in the opinion of the Principal Investigator, would compromise participant safety, interfere with study procedures, or affect data integrity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sequence A: Sham nVNS First
Participants complete the common baseline condition with sham nVNS and sham intermittent hypercapnia, followed by sham nVNS + active intermittent hypercapnia and then active nVNS + active intermittent hypercapnia.
Device: Active noninvasive vagus nerve stimulation
Active cervical noninvasive vagus nerve stimulation (nVNS) will be delivered using the gammaCore device. Participants will receive two consecutive 2-minute stimulation applications, one on each side of the neck. Stimulation intensity will be adjusted by the participant to a perceptible but comfortable level. The device delivers 1-ms pulses of 5-kHz sine waves at 25 Hz.
Other Names:
  • gammaCore
Device: Sham noninvasive vagus nerve stimulation
Participants will undergo the same application procedure and duration as active nVNS using a sham device. The sham device is similar in appearance to the active device and produces vibration and audible feedback but does not deliver active electrical stimulation.
Other Names:
  • sham gammacore
Procedure: Active intermittent hypercapnia
Participants will intermittently breathe a controlled hypercapnic gas mixture containing approximately 5% carbon dioxide, 21% oxygen, and balance nitrogen through a noninvasive mask. The intervention consists of three approximately 10-minute hypercapnia blocks according to the study protocol, with respiratory and physiological monitoring throughout.
Other Names:
  • 5% carbon dioxide exposure
Procedure: Sham intermittent hypercapnia
Participants will undergo the same mask-based breathing procedures used for the intermittent hypercapnia condition but will breathe room air rather than the hypercapnic gas mixture. This condition serves as the baseline/sham hypercapnia condition.
Other Names:
  • Room air exposure
Behavioral: Guided breathing
Participants will complete approximately 10 minutes of guided breathing during study visits. Breathing will be standardized using verbal instruction from study personnel and/or visual or auditory pacing cues, which may include commercially available applications such as Elite HRV or study-specific pacing aids. The guided breathing procedure is intended to standardize breathing timing and pacing during physiological monitoring and intervention procedures and is not used for diagnosis, treatment, or medical decision-making.
Experimental: Sequence B: Active nVNS First
Participants complete the common baseline condition with sham nVNS and sham intermittent hypercapnia, followed by active nVNS + active intermittent hypercapnia and then sham nVNS + active intermittent hypercapnia.
Device: Active noninvasive vagus nerve stimulation
Active cervical noninvasive vagus nerve stimulation (nVNS) will be delivered using the gammaCore device. Participants will receive two consecutive 2-minute stimulation applications, one on each side of the neck. Stimulation intensity will be adjusted by the participant to a perceptible but comfortable level. The device delivers 1-ms pulses of 5-kHz sine waves at 25 Hz.
Other Names:
  • gammaCore
Device: Sham noninvasive vagus nerve stimulation
Participants will undergo the same application procedure and duration as active nVNS using a sham device. The sham device is similar in appearance to the active device and produces vibration and audible feedback but does not deliver active electrical stimulation.
Other Names:
  • sham gammacore
Procedure: Active intermittent hypercapnia
Participants will intermittently breathe a controlled hypercapnic gas mixture containing approximately 5% carbon dioxide, 21% oxygen, and balance nitrogen through a noninvasive mask. The intervention consists of three approximately 10-minute hypercapnia blocks according to the study protocol, with respiratory and physiological monitoring throughout.
Other Names:
  • 5% carbon dioxide exposure
Procedure: Sham intermittent hypercapnia
Participants will undergo the same mask-based breathing procedures used for the intermittent hypercapnia condition but will breathe room air rather than the hypercapnic gas mixture. This condition serves as the baseline/sham hypercapnia condition.
Other Names:
  • Room air exposure
Behavioral: Guided breathing
Participants will complete approximately 10 minutes of guided breathing during study visits. Breathing will be standardized using verbal instruction from study personnel and/or visual or auditory pacing cues, which may include commercially available applications such as Elite HRV or study-specific pacing aids. The guided breathing procedure is intended to standardize breathing timing and pacing during physiological monitoring and intervention procedures and is not used for diagnosis, treatment, or medical decision-making.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of Completing the Multimodal Study Protocol
Time Frame: From enrollment through completion of the approximately 1-week study protocol
Feasibility will be assessed as the number and proportion of enrolled participants who complete the planned in-clinic visits, intervention procedures, and scheduled at-home Applied Cognition GF Monitor recordings. Reasons for incomplete procedures or study withdrawal will also be documented.
From enrollment through completion of the approximately 1-week study protocol
Incidence of Study-Related Adverse Events
Time Frame: From initiation of study procedures through completion of the approximately 1-week protocol
Safety will be assessed by the number and proportion of participants experiencing adverse events during or following study procedures. Adverse events will be documented with respect to type, severity, timing, and relationship to intermittent hypercapnia, guided breathing, nVNS, physiological monitoring, or blood collection.
From initiation of study procedures through completion of the approximately 1-week protocol
Change in Participant-Reported Tolerability During Intervention Procedures
Time Frame: During intervention visits on Days 3 and 5, before and after each 10-minute hypercapnia block and immediately after the overall hypercapnia protocol, up to 1 week
Participants will rate dizziness, stress/anxiety, and overall discomfort on 1-to-10 numeric rating scales before and after each 10-minute intermittent hypercapnia block and following completion of the overall hypercapnia protocol. Additional symptoms and tolerability concerns will also be recorded.
During intervention visits on Days 3 and 5, before and after each 10-minute hypercapnia block and immediately after the overall hypercapnia protocol, up to 1 week
Proportion of Planned Physiological Recordings With Usable Data
Time Frame: From baseline through completion of scheduled intervention, recovery, and overnight monitoring periods, up to 1 week
The proportion of planned physiological recording sessions that yield usable data will be assessed across the Applied Cognition GF Monitor and respiratory, cardiovascular, and autonomic monitoring systems. Device failures, incomplete recordings, and technical problems resulting in unavailable or unusable data will be documented.
From baseline through completion of scheduled intervention, recovery, and overnight monitoring periods, up to 1 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in EIS-Derived Brain Parenchymal Resistance During Intervention
Time Frame: During each intervention visit, from pre-intervention baseline through the post-intervention recovery period, approximately 1.5-2 hours
Electrical impedance spectroscopy (EIS) obtained with the Applied Cognition GF Monitor will be used to quantify changes in brain parenchymal resistance across baseline, intervention, and recovery periods. Within-participant responses will be compared across the study intervention conditions.
During each intervention visit, from pre-intervention baseline through the post-intervention recovery period, approximately 1.5-2 hours
Change in Overnight EIS-Derived Brain Parenchymal Resistance Following Intervention
Time Frame: Baseline Nights 1 and 2 compared with the overnight recording following the first intervention visit, within approximately 3 days
Overnight EIS-derived brain parenchymal resistance measured following the first intervention visit will be compared with measurements obtained during the baseline overnight monitoring nights to explore intervention-associated changes in overnight physiology.
Baseline Nights 1 and 2 compared with the overnight recording following the first intervention visit, within approximately 3 days
Change in Carbon Dioxide Levels During Intervention
Time Frame: During each intervention visit, from pre-intervention baseline through post-intervention recovery, approximately 1.5-2 hours
Transcutaneous carbon dioxide and/or end-tidal carbon dioxide will be measured continuously or repeatedly during baseline, intermittent hypercapnia, and recovery to characterize the physiological response to controlled carbon dioxide exposure.
During each intervention visit, from pre-intervention baseline through post-intervention recovery, approximately 1.5-2 hours
Change in Peripheral Oxygen Saturation During Intervention
Time Frame: During each intervention visit, from pre-intervention baseline through post-intervention recovery, approximately 1.5-2 hours
Peripheral oxygen saturation (SpO2) will be monitored during baseline, intervention, and recovery periods to characterize respiratory responses and support participant safety monitoring.
During each intervention visit, from pre-intervention baseline through post-intervention recovery, approximately 1.5-2 hours
Change in Respiratory Rate During Intervention
Time Frame: During each intervention visit, from pre-intervention baseline through post-intervention recovery, approximately 1.5-2 hours
Respiratory rate will be measured during baseline, guided breathing, intermittent hypercapnia, and recovery periods to characterize intervention-associated respiratory responses.
During each intervention visit, from pre-intervention baseline through post-intervention recovery, approximately 1.5-2 hours
Change in Tidal Volume During Intervention
Time Frame: During each intervention visit, from pre-intervention baseline through post-intervention recovery, approximately 1.5-2 hours
Tidal volume will be measured when available using respiratory monitoring equipment during baseline, intervention, and recovery periods.
During each intervention visit, from pre-intervention baseline through post-intervention recovery, approximately 1.5-2 hours
Change in Minute Ventilation During Intervention
Time Frame: During each intervention visit, from pre-intervention baseline through post-intervention recovery, approximately 1.5-2 hours
Minute ventilation will be measured when available during baseline, guided breathing, intermittent hypercapnia, and recovery periods to characterize intervention-associated respiratory responses.
During each intervention visit, from pre-intervention baseline through post-intervention recovery, approximately 1.5-2 hours
Change in Heart Rate During Intervention
Time Frame: During each intervention visit, from pre-intervention baseline through post-intervention recovery, approximately 1.5-2 hours
Heart rate will be measured continuously or repeatedly during baseline, guided breathing, nVNS, intermittent hypercapnia, and recovery periods to characterize intervention-associated cardiovascular and autonomic responses.
During each intervention visit, from pre-intervention baseline through post-intervention recovery, approximately 1.5-2 hours
Change in Heart Rate Variability During Intervention
Time Frame: During each intervention visit, from pre-intervention baseline through post-intervention recovery, approximately 1.5-2 hours
Heart rate variability-related measures derived from ECG or heart-rate monitoring will be evaluated across baseline, guided breathing, nVNS, intermittent hypercapnia, and recovery periods to characterize autonomic responses.
During each intervention visit, from pre-intervention baseline through post-intervention recovery, approximately 1.5-2 hours
Change in Blood Pressure During Intervention
Time Frame: During each intervention visit, from pre-intervention baseline through post-intervention recovery, approximately 1.5-2 hours
Systolic and diastolic blood pressure will be assessed at predefined timepoints during study procedures to characterize cardiovascular responses and support participant safety monitoring.
During each intervention visit, from pre-intervention baseline through post-intervention recovery, approximately 1.5-2 hours
Change in Plasma Neurodegenerative and Glymphatic-Associated Biomarkers
Time Frame: Approximately t=0, t=45 minutes, and t=60 minutes relative to the intervention period during each intervention visit
Serial blood samples will be analyzed for plasma alpha-synuclein, neurofilament light chain (NfL), glial fibrillary acidic protein (GFAP), amyloid-beta 1-42 (Aβ1-42), amyloid-beta 1-40 (Aβ1-40), and phosphorylated tau 217 (pTau217). Changes in biomarker concentrations across sampling timepoints will be evaluated within participants and across intervention conditions.
Approximately t=0, t=45 minutes, and t=60 minutes relative to the intervention period during each intervention visit

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Consensus Sleep Diary Total Sleep Time
Time Frame: Each morning following scheduled study nights, up to 1 week
Total sleep time will be derived from the Consensus Sleep Diary based on participant-reported sleep and wake times for the previous night.
Each morning following scheduled study nights, up to 1 week
Consensus Sleep Diary Sleep Onset Latency
Time Frame: Each morning following scheduled study nights, up to 1 week
Sleep onset latency will be derived from the Consensus Sleep Diary as the participant-reported time from attempting to fall asleep to sleep onset.
Each morning following scheduled study nights, up to 1 week
Consensus Sleep Diary Wake After Sleep Onset
Time Frame: Each morning following scheduled study nights, up to 1 week
Wake after sleep onset will be derived from the Consensus Sleep Diary based on participant-reported nighttime awakenings after initial sleep onset.
Each morning following scheduled study nights, up to 1 week
Consensus Sleep Diary Sleep Efficiency
Time Frame: Each morning following scheduled study nights, up to 1 week
Sleep efficiency will be derived from the Consensus Sleep Diary as the percentage of time in bed spent asleep.
Each morning following scheduled study nights, up to 1 week
Groningen Sleep Quality Scale Score
Time Frame: Following scheduled overnight study periods during the approximately 1-week protocol
Subjective sleep quality will be assessed using the Groningen Sleep Quality Scale (GSQS). Higher scores indicate poorer perceived sleep quality.
Following scheduled overnight study periods during the approximately 1-week protocol
Karolinska Sleepiness Scale Score
Time Frame: At predefined study assessment timepoints during the approximately 1-week protocol
Momentary subjective sleepiness will be assessed using the Karolinska Sleepiness Scale, ranging from 1 (extremely alert) to 9 (very sleepy, fighting sleep).
At predefined study assessment timepoints during the approximately 1-week protocol
System Usability Scale Score
Time Frame: At completion of study device use, within the approximately 1-week protocol
Usability of study devices and procedures will be assessed using the 10-item System Usability Scale (SUS), which provides an overall measure of perceived system usability.
At completion of study device use, within the approximately 1-week protocol
Participant-Reported Applied Cognition Device Tolerability
Time Frame: During device use and at completion of scheduled monitoring periods, within approximately 1 week
Participants will report discomfort, irritation, technical difficulties, and other issues associated with use of the Applied Cognition GF Monitor and other study devices.
During device use and at completion of scheduled monitoring periods, within approximately 1 week
Composite Autonomic Symptom Score-31
Time Frame: During the study intake/baseline assessment
Autonomic symptom burden may be characterized using the Composite Autonomic Symptom Score-31 (COMPASS-31), including orthostatic, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor domains.
During the study intake/baseline assessment
Subjective Overnight Sleep Parameters
Time Frame: Each morning following scheduled study nights during the approximately 1-week protocol
Consensus Sleep Diary measures may include total sleep time, sleep onset latency, wake after sleep onset, number and duration of awakenings, sleep efficiency, and perceived sleep quality.
Each morning following scheduled study nights during the approximately 1-week protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Florida Institute for Human and Machine Cognition

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Applied Cognition

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Toshiya Miyatsu, PhD, Florida Institute for Human & Machine Cognition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-2026-0021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data may be shared with study collaborators, including Applied Cognition, Inc., for device-related processing, feature extraction, and analyses related to the study objectives. Applied Cognition will receive physiological data generated by the GF Monitor for processing of electrical impedance spectroscopy (EIS) and related measures. Additional de-identified physiological, demographic, clinical, or intervention-related data may be shared when necessary to support prespecified or collaborative analyses. Direct participant identifiers will not be shared.

IPD Sharing Time Frame

During study conduct and analysis, and following completion of data collection as needed for study-related analyses.

IPD Sharing Access Criteria

Access will be limited to authorized study collaborators for analyses consistent with the study objectives and subject to applicable institutional, IRB, confidentiality, and data-use requirements. Shared participant-level data will be de-identified.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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