The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study (ESSENTIAL)

August 4, 2026 updated by: California Pacific Medical Center Research Institute

The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults (ESSENTIAL) Study

The Effects of Successful OSA TreatmENT on Memory and AD BIomarkers in Older AduLts (ESSENTIAL) study is a 5-year, multicenter randomized open-label trial that will screen 400 cognitively normal older adults recruited from well-established sleep clinics at 4 academic medical centers, with newly diagnosed moderate-severe OSA. An expected 200 OSA patients will be then randomized to one of two groups: i) a 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an "effective" AHI4%< 10/hour and AHI3A<20/hour (see below); ii) a waitlist control group to receive treatment at the conclusion of the 3-month intervention period. Both groups will continue follow-up for 24 months on stable therapy to determine if sustained improvements in sleep are associated with improvement in cognitive function and AD biomarkers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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

The prevalence of Alzheimer disease (AD) is high and projected to increase. While there are multiple risk factors for AD, epidemiological data suggests that ~15% of AD risk may be attributed to sleep problems. Obstructive sleep apnea (OSA) is common among the elderly (30-55%), and the investigators have shown that cognitively normal older women with OSA have nearly double the risk of developing mild cognitive impairment (MCI) or dementia over 5 years. Further, the investigators have shown that in normal elderly, OSA predicts longitudinal increases in AD biomarkers. Our preliminary data also show that after positive airway pressure (PAP) withdrawal, OSA patients treated with PAP experienced significant overnight increases in plasma neurofilament light (NfL), a marker of neural injury. The present study is designed to overcome challenges identified in previous trials of treatment of OSA to slow cognitive decline and progression to AD. First, the most effective treatment for OSA, PAP therapy, has poor adherence (typically only 50% are adequately treated). Other common therapies include oral appliance therapy (OAT) which tends to be better tolerated but less effective. The investigators have piloted and propose for this study a rapid multimodal therapy initiation (RMMT) which ensures subjects will have effective therapy for their OSA that reduces OSA severity to AHI4%<10/hour and AHI3A (AKA pRDI) < 20/hour within 4 months. Second, most prior OSA treatment trials have focused primarily on symptomatic older adults (e.g. patients with MCI recruited from memory clinics), whereas early intervention in pre-symptomatic individuals may have stronger impact in preventing progression to AD. The investigators propose to enroll cognitively normal adults with newly diagnosed moderate-severe OSA (AHI4% >20/hour or AHI3A > 40/hour). Finally, selection of cognitive outcomes most responsive to OSA therapy has proved challenging. The Effects of Successful OSA TreatmENT on Memory and AD BIomarkers in Older AduLts (ESSENTIAL) study is a 5-year, multicenter randomized open-label trial that will screen 400 cognitively normal older adults (MoCA≥24, Clinical Dementia Rating [CDR]=0), ages 55-75, recruited from well-established sleep clinics at 4 academic medical centers, with newly diagnosed moderate-severe OSA (AHI4% >20/hour or AHI3A > 40/hour). An expected 200 OSA patients will be then randomized to one of two groups: i) a 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an "effective" AHI4%< 10/hour and AHI3A<20/hour (see below); ii) a waitlist control group to receive treatment at the conclusion of the 3-month intervention period. Both groups will continue follow-up for 24 months on stable therapy to determine if sustained improvements in sleep are associated with improvement in cognitive function and AD biomarkers. Both arms will include PSG and actigraphy, sleep-dependent memory and other cognitive evaluations, and blood draws at baseline, 3 and 24 months, with cognitive evaluation only at 12 months. Structural brain MRI will be performed at baseline. Because the investigators anticipate that 150 of 200 subjects will be well treated at 24 months, and 50 will not be, the investigators will additionally recruit ~50 subjects (on average 13 subjects per clinical site) with the same inclusion criteria who refuse treatment. These 50 subjects will perform baseline (blood draw and cognitive evaluations), 12-month (cognitive evaluation only), and 24-month (blood draw and cognitive evaluations) visits, allowing for a 24-month comparison of ~150 subjects with adequate treatment over 24 months to 100 subjects with inadequate treatment over 24 months. Our aims are: 1) To compare 3-month change in plasma AD biomarkers (NfL, p-tau, Aβ) in those randomized to OSA treatment and wait-list control groups (via both intention-to-treat and per-protocol analyses); 2) To test differences at 3 months in sleep-dependent declarative memory and cognitive scores (PACC and sub-domains) between the OSA treatment and wait-list control groups (via both intention-to-treat and per-protocol analyses); 3) To compare 24-month changes in AD biomarkers (NfL, p-tau, Aβ) and cognition in all successfully treated subjects and untreated controls.

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.
200

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.

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • University of Arizona
        • Principal Investigator:
          • Sairam Parsasarathy, MD
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • New York University
        • Principal Investigator:
          • Ricardo Osorio, MD
        • Principal Investigator:
          • Acibiades Rodriguez, MD
      • New York, New York, United States, 10023
        • Recruiting
        • Mount Sinai
        • Principal Investigator:
          • Andrew Varga, MD
        • Principal Investigator:
          • Jay Guevarra, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh
        • Principal Investigator:
          • Sanjay Patel, MD

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

No

Description

Inclusion Criteria:

  • Cognitively normal (TiCS ≥29)
  • Age 55-85 years
  • Moderate - severe OSA defined as AHI4 ≥20 events/hour or AHI3A>40/hr using a hypopnea criterion of a 4% oxygen desaturation (AHI4) or 3% oxygen desaturation and/or EEG arousal (AHI3A), or equivalent based on in-home testing - Testing must have been completed in past 12 months or confirmed by repeat test
  • Not currently on therapy for OSA and has not received treatment for OSA for at least 6months
  • Able and willing to be treated for OSA (Treatment group)
  • Fluency in English or Spanish

Exclusion Criteria:

  • Documented diagnosis of chronic insomnia, or sleep onset insomnia based on Insomnia Severity Index - an answer of severe or very severe in the screening form
  • Documented diagnosis of circadian rhythm disorder
  • Any current use of supplemental oxygen
  • Other sleep-related breathing disorders (central sleep apnea, etc) based on AASM criteria
  • Current shift work involving night shift (regular work between 12am and 6am or night shift) within the past 6 mo
  • Anticipated scheduled bariatric surgery within the next 3 months
  • Chronic regular (> 2 nights per week) of cannabis for sleep
  • Chronic regular use (> 2 nights per week) of sedatives/hypnotics for sleep
  • Diagnosis of uncontrolled psychiatric disease in the last six months , and/or history of schizophrenia or bipolar disorder. Controlled conditions will include major depressive disorder, panic disorder, generalized anxiety disorder, OCD, substance use disorders, and alcohol abuse/dependence. Personality disorders and neurodevelopmental disorders (e.g. autism, ADHD) are allowed if cognition is within normal limits.
  • Taking methylphenidate for ADHD. Unless on stable dose which will be reviewed by the PI to determine.
  • Taking GLP-1 agonist semaglutide (Ozempic, Wegovy, Rybelsus), or tirzepatide (Mounjaro, Zepbound), or similar for weightloss, and planning to lose an additional 20lbs or more at the time of enrollment. PI Discretion for determination of why they are taking the drug based on conversation with subject and medical chart, will be documented in form of Note-to-file in the subject's records
  • Presence of other comorbid condition that would lead to inability to complete the study protocol (including follow-up for 2 years), or that would affect cognition (e.g. clinically relevant endocrine or hematological conditions).
  • Does not have a regular sleeping environment (i.e., sleeps in a different setting > 2 nights per week).
  • Currently pregnant or planning to become pregnant.
  • Prior diagnosis of a Central nervous system (CNS) disease, such as multiple sclerosis, stroke, Parkinson's disease, Alzheimer's disease, epilepsy, a loss of consciousness > 24 hours, or traumatic brain injury as identified by the Cumulative Illness Rating Scale for Geriatrics (CIRS). Participants who are diagnosed with MCI or Alzheimer's disease based on neuropsychological testing will be excluded. Delirium in the last 12 months.
  • Near-miss or prior automobile accident "due to sleepiness" within the past 12 months.
  • Employed as a commercial driver during the study (for example, bus drivers, train engineers, airplane pilots).
  • Any use of neuroleptics, benzodiazepines, barbiturates, opiates or anti-amyloid therapies.
  • Use of other cognitive enhancing drugs will also be excluded if initiated in the last 3 months, or not on stable dose.
  • Consumption of >14 alcohol drinks per week, unless alcohol consumption can be reduced if initiated in the last 3 months.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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.
Active Comparator: 3-month OSA treatment
A 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an "effective" AHI3a<15 (rapid multi-modal treatment RMMT).
Device: Positive airway pressure
Positive airway pressure (PAP) therapy is a sleep apnea treatment that uses a stream of compressed air to support the airway during sleep. With PAP therapy, a mask is worn during sleep and a portable machine gently blows pressurized room air from into your upper airway through a tube connected to the mask. This positive airflow helps keep the airway open, preventing the collapse that occurs during apnea, thus allowing normal breathing.
Other Names:
  • CPAP
Device: Oral appliance therapy
Oral appliance therapy involves the use of a dental appliance or oral mandibular advancement device that prevents the tongue from blocking the throat and/or advances the lower jaw forward. These devices help keep the airway open during sleep.
Other Names:
  • OAT
  • ProSomnus
  • Somnomed
Device: Positional therapy
A NightShift Sleep Positioner (Advanced Brain Monitoring) is a neck vibration device, FDA approved to treat positional sleep apnea. The device detects patient supine position and delivers a small vibratory signal to the back of the neck to prompt position change.
Other Names:
  • NightShift Sleep Positioner
Other: Waitlist control group
A waitlist control group to receive treatment at the conclusion of the 3-month intervention period.
Device: Positive airway pressure
Positive airway pressure (PAP) therapy is a sleep apnea treatment that uses a stream of compressed air to support the airway during sleep. With PAP therapy, a mask is worn during sleep and a portable machine gently blows pressurized room air from into your upper airway through a tube connected to the mask. This positive airflow helps keep the airway open, preventing the collapse that occurs during apnea, thus allowing normal breathing.
Other Names:
  • CPAP
Device: Oral appliance therapy
Oral appliance therapy involves the use of a dental appliance or oral mandibular advancement device that prevents the tongue from blocking the throat and/or advances the lower jaw forward. These devices help keep the airway open during sleep.
Other Names:
  • OAT
  • ProSomnus
  • Somnomed
Device: Positional therapy
A NightShift Sleep Positioner (Advanced Brain Monitoring) is a neck vibration device, FDA approved to treat positional sleep apnea. The device detects patient supine position and delivers a small vibratory signal to the back of the neck to prompt position change.
Other Names:
  • NightShift Sleep Positioner

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
Change in overnight memory retention on the A-B verbal paired associates task
Time Frame: 3 months
Mean change in percent correct memory
3 months
Change in overnight memory retention on the A-B verbal paired associates task
Time Frame: 12 months
Mean change in percent correct memory
12 months
Change in overnight memory retention on the A-B verbal paired associates task
Time Frame: 24 months
Mean change in percent correct memory
24 months
Change in Aβ42/ Aβ40 ratio
Time Frame: 3 months
Mean change in the Aβ42/ Aβ40 ratio in picograms per millimeter (pg/ml)
3 months
Change in Aβ42/ Aβ40 ratio
Time Frame: 24 months
Mean change in the Aβ42/ Aβ40 ratio in picograms per millimeter (pg/ml)
24 months
Change in Plasma P-tau181
Time Frame: 3 months
Mean change in p-tau181 levels in the plasma in picograms per millimeter (pg/ml)
3 months
Change in Plasma P-tau181
Time Frame: 24 months
Mean change in p-tau181 levels in the plasma in picograms per millimeter (pg/ml)
24 months
Change in P-tau217
Time Frame: 3 months
Mean change in p-tau217 levels in the plasma in picograms per millimeter (pg/ml)
3 months
Change in P-tau217
Time Frame: 24 months
Mean change in p-tau217 levels in the plasma in picograms per millimeter (pg/ml)
24 months
Change in Neurofibrilary light (NfL)
Time Frame: 3 months
Mean change in NfL levels in the plasma in picograms per millimeter (pg/ml)
3 months
Change in Neurofibrilary light (NfL)
Time Frame: 24 months
Mean change in NfL levels in the plasma in picograms per millimeter (pg/ml)
24 months
Preclinical Cognitive Composite Score
Time Frame: 3 months
Mean change in Preclinical Cognitive Composite Score.
3 months
Preclinical Cognitive Composite Score
Time Frame: 12 months
Mean change in Preclinical Cognitive Composite Score.
12 months
Preclinical Cognitive Composite Score
Time Frame: 24 months
Mean change in Preclinical Cognitive Composite Score.
24 months

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 Task-switching Accuracy
Time Frame: 3 months
Change in Task-switching Mean Percent Accuracy
3 months
Change in Task-switching Accuracy
Time Frame: 12 months
Change in Task-switching Mean Percent Accuracy
12 months
Change in Task-switching Accuracy
Time Frame: 24 months
Change in Task-switching Mean Percent Accuracy
24 months
Change in Task-switching Reaction Time
Time Frame: 3 months
Change in Task-switching Mean Reaction Time in milliseconds
3 months
Change in Task-switching Reaction Time
Time Frame: 12 months
Change in Task-switching Mean Reaction Time in milliseconds
12 months
Change in Task-switching Reaction Time
Time Frame: 24 months
Change in Task-switching Mean Reaction Time in milliseconds
24 months
Change in Psychomotor Vigilance Task (PVT) lapses
Time Frame: 3 months
Mean change in number of lapses
3 months
Change in Psychomotor Vigilance Task (PVT) lapses
Time Frame: 12 months
Mean change in number of lapses
12 months
Change in Psychomotor Vigilance Task (PVT) lapses
Time Frame: 24 months
Mean change in number of lapses
24 months
Change in Psychomotor Vigilance Task (PVT) reaction time
Time Frame: 3 months
Mean change in median reaction time in milliseconds.
3 months
Change in Psychomotor Vigilance Task (PVT) reaction time
Time Frame: 12 months
Mean change in median reaction time in milliseconds.
12 months
Change in Psychomotor Vigilance Task (PVT) reaction time
Time Frame: 24 months
Mean change in median reaction time in milliseconds.
24 months

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
Cognitive Impairment Severity
Time Frame: Baseline
Severity of cognitive impairment based on normed cutoffs with the National Alzheimer's Coordinating Centers Uniform Data Set-3 (UDS-3) assessment.
Baseline
Cognitive Impairment Severity
Time Frame: 24 months
Severity of cognitive impairment based on normed cutoffs with the National Alzheimer's Coordinating Centers Uniform Data Set-3 (UDS-3) assessment.
24 months
Clinical Dementia Rating (CDR) Scale (0-3)
Time Frame: Baseline
Clinical Dementia Rating on a scale of 0-3 based on clinical assessment, 0 being no impairment, and 3 being severe impairment.
Baseline
Sleepiness Score
Time Frame: Baseline
Epworth Sleepiness Scale (ESS) Questionnaire Score. Higher scores mean more severe sleepiness.
Baseline
Sleepiness Score
Time Frame: 3 months
Epworth Sleepiness Scale (ESS) Questionnaire Score. Higher scores mean more severe sleepiness.
3 months
Sleepiness Score
Time Frame: 24 months
Epworth Sleepiness Scale (ESS) Questionnaire Score. Higher scores mean more severe sleepiness.
24 months
Insomnia Severity
Time Frame: Baseline
Insomnia Severity Index (ISI) Questionnaire Score. Higher scores mean more severe insomnia symptoms.
Baseline
Insomnia Severity
Time Frame: 3 months
Insomnia Severity Index (ISI) Questionnaire Score. Higher scores mean more severe insomnia symptoms.
3 months
Insomnia Severity
Time Frame: 24 months
Insomnia Severity Index (ISI) Questionnaire Score. Higher scores mean more severe insomnia symptoms.
24 months
Psychiatric Symptom Questionnaires: Geriatric Depression Scale (GDS)
Time Frame: Baseline
Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Baseline
Psychiatric Symptom Questionnaires: Hamilton Anxiety Rating Scale (HAM-A)
Time Frame: Baseline
Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Baseline
Psychiatric Symptom Questionnaires: Clinician-Administered PTSD Scale (CAPS)
Time Frame: Baseline
CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20). Severity scores range from 0-4, with 0 being absent to 4 being extreme/incapacitating.
Baseline

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.
California Pacific Medical Center Research Institute

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.
New York University
Icahn School of Medicine at Mount Sinai
University of Pittsburgh
National Institute on Aging (NIA)
University of Arizona

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: Katie L Stone, PhD, California Pacific Medical Center Research Institute
  • Principal Investigator: Ricardo Osorio, MD, New York University
  • Principal Investigator: Andrew Varga, MD, Icahn School Of Medicine At Mount Sinai

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 (Actual)

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.
August 29, 2024

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.
June 30, 2027

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.
May 31, 2028

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).
May 22, 2023

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.
August 4, 2023

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.
August 14, 2023

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.
August 6, 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.
August 4, 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.
August 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.
  • AG080609

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The final research data will be available in acceptable formats commonly accepted for documenting and supporting research findings. All data will be released and/or shared as soon as feasible without compromising privacy concerns, federal and state confidentiality concerns, proprietary interests, national security interests, or law enforcement activities. The final research data will not contain any patient identifiers. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement.

IPD Sharing Time Frame

Research data that documents, supports, and validates research findings will be available after the main findings from the final research data set are accepted for publication. We anticipate data will be available starting in January 2029 and will be available on an NIH-sponsored platform for as long as the agency supports it.

IPD Sharing Access Criteria

Data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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