Sounds Locked to ElectroEncephalogram Phase For the Acceleration of Sleep Onset Time (SLEEPFAST)

February 15, 2024 updated by: Elemind Technologies, Inc.

Non-Invasive, Non-pharmacologic, Computer Interface Approach to Modulate Electroencephalogram (EEG) Potentials, Alertness and Sleep With Acoustic Stimulation

This study seeks to test whether auditory stimulation delivered at specific phases of the alpha oscillation (as measured by electroencephalogram) can accelerate sleep onset.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

In healthy sleepers, cortical alpha oscillations are present during the transition from wakefulness to sleep, and dissipate at sleep onset. For individuals with insomnia, alpha power is elevated during the wake-sleep transition and can persist throughout the night. This study tests whether a wearable device that delivers auditory stimulation phase-locked to alpha oscillations can accelerate sleep onset in healthy adults who report difficulties falling and staying asleep. The device is a prototype of the Elemind Neuromodulation system (ENMod). The ENMod is a wireless headband that measures brain signals, computes the phase of neural oscillations in specific frequency bands, and delivers audible pink noise pulses at specific times relative to the instantaneous phase of neural oscillations. In this study, we ask participants to wear the ENMod headband at home while going to sleep. The device is programmed to record EEG activity and, during the transition from wakefulness to sleep, deliver phase-locked sounds that are intended to interact with the participants neural activity and accelerate sleep onset.

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 (Actual)

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
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02139
        • Elemind Technologies, Inc

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

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Able to provide informed consent after reading and answering questions in written English
  • Self-report that it takes 30 minutes on average or more to fall asleep
  • Subthreshold to Moderately severe Clinical insomnia symptoms (ISI < 21)
  • Subthreshold to Moderately severe Clinical insomnia (PSQI > 6)
  • Minimal risk for severe Generalized Anxiety Disorder (GAD-7 < 15)
  • Minimal risk for severe Generalized Anxiety Disorder (GAD-7 < 15)
  • Individuals that are not actively being treated for anxiety, insomnia, ADHD or other psychological disorders with medications
  • Self-report of difficulty staying asleep "Moderate," "Severe," or "Very Severe"
  • Self report of waking up in the middle of the night/early morning one or more times per week

Exclusion Criteria:

  • Unable to read or understand English
  • Body Mass Index (weight/height ratio) >33
  • Self-report of being diagnosed with apnea
  • Current or past history of a neurological disorder or psychiatric illness
  • Self-report that it takes less than 30 minutes to fall asleep on average
  • Severe Clinical insomnia symptoms (ISI > 21)
  • Good sleepers (PSQI < 6)
  • High risk for severe Generalized Anxiety Disorder (GAD-7 > 15)
  • Moderate to high risk for alcohol abuse disorder (AUDIT >6)
  • individuals that are actively being treated for anxiety, insomnia, ADHD or other psychological disorders with medications
  • Consumption of more than 4 cups of Caffeinated beverages per day
  • Any caffeine < 6hrs prior to each recording session (e.g. coffee, tea, caffeinated sodas etc.)
  • Any seizures or family history of seizures
  • History of migraine
  • History of brain related injury or unexplained loss of consciousness
  • Cardiac pacemaker or intracranial metal implant
  • Pregnant
  • Taking any anti-depressants, stimulants, medication for hypertension or hypotension and/or cannabis derived products
  • Cochlear implant in either ear
  • Diagnosed with hearing impairment or deafness
  • Works night shifts any night of the week

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: Crossover Assignment
  • Masking: Double

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: Sleep Onset Latency Crossover
Arm 1 is a crossover arm in which participants receive one block of active stimulation (experimental) and a second block in which the device is worn and actively recording, but not delivering phase-locked auditory stimulation (sham). The order of blocks is randomized for each participant.
Device: Elemind Neuromodulation (ENMod)
The ENMod is a headband that measures electroencephalogram (EEG) activity, computes the phase of neural oscillations in real-time, and delivers auditory pulses intended to interact with ongoing neural oscillations.
Experimental: Wake After Sleep Onset
This arm tests active stimulation during sleep onset, as well as additional stimulation if participants wake up during the night. One of 4 possible conditions are randomized for each stimulation even (within subject and within nights): Stimulation locked to alpha peak phase, stimulation locked to alpha trough phase, white noise (active sham), and no sound (control).
Device: Elemind Neuromodulation (ENMod)
The ENMod is a headband that measures electroencephalogram (EEG) activity, computes the phase of neural oscillations in real-time, and delivers auditory pulses intended to interact with ongoing neural oscillations.

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 Sleep Onset Latency (SOL) from Sham Block Compared to Stimulation Block
Time Frame: At the completion of the study (14 days), including at least 4 days in each block.
SOL will be determined using objective EEG-based metrics (e.x. time to first observed sleep spindle) derived from recommendations set forth by the American Academy of Sleep Medicine (AASM). SOL will be assessed for each study day during the sham block in which the device is worn but inactive and compared to SOL for the days in the stimulation block, in which the device is actively delivering auditory stimulation. Subjects will randomly be assigned in regards to the order of sham and stimulation blocks.
At the completion of the study (14 days), including at least 4 days in each block.

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 Sleep Efficiency During Sham Block Compared to Stimulation Block
Time Frame: At the completion of the study (14 days), including at least 4 days in each block.
Sleep efficiency, defined as the percentage of time spent asleep out of the total time spent in bed will assessed for each study day during the sham block in which the device is worn but inactive and compared to the sleep efficiency for each day in the stimulation block, in which the device is actively delivering auditory stimulation. Subjects will randomly be assigned in regards to the order of sham and stimulation blocks.
At the completion of the study (14 days), including at least 4 days in each block.
Sleep Onset Latency After Wake After Sleep Onset Events (WASO) During Sham Stimulation Sessions Compared to Active Stimulation Sessions
Time Frame: At the completion of the study (7-14 days).
Sleep onset latency will be measured after middle-of-night wake up events using EEG-based metrics according to guidelines set forth by the American Academy of Sleep Medicine (AASM). Stimulation condition (sham or active) will be randomized for each WASO event (including events within a single night as well as across all nights). At the completion of the study, SOL will be compared for WASO events in which sham stimulation was delivered compared to WASO events in which active stimulation was delivered.
At the completion of the study (7-14 days).
Change in Subjective Sleep Onset Latency (SOL) from Sham Block Compared to Stimulation Block
Time Frame: At the completion of the study (14 days).
Subject-reported time to fall asleep will be assessed using the results from a questionnaire that includes the first 9 questions from the Consensus Sleep Diary (Carney et al., 2012). This survey asks the participant to report bed time, wake time, the amount of time it took to fall asleep, the number of awakenings during the night and the total duration of such awakenings. The questionnaire also asks the subject to rate quality of sleep on a 5-point scale from very poor to very good. The reported time to fall asleep on days during the sham block will be compared to the same metric reported on days during the stimulation block.
At the completion of the study (14 days).
Change in Subjective Daytime Sleepiness (Karolinska Sleepiness Scale) from Sham Block Compared to Stimulation Block
Time Frame: At the completion of the study (14 days).
Subject-reported feelings of sleepiness and alertness during the day will be assessed using the Karolinska Sleepiness Scale (KSS) questionnaire. This is a single question scale on which sleepiness is assessed using a score from 1-9, with 1 representing a level of high alertness, and 9 representing very sleepy. The reported KSS score during the sham block will be compared to the same metric reported on days during the stimulation block.
At the completion of the study (14 days).

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.
Elemind Technologies, Inc.

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.
February 2, 2020

Primary Completion (Actual)

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 15, 2023

Study Completion (Actual)

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.
January 10, 2024

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).
February 6, 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.
February 14, 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.
February 24, 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.
February 20, 2024

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.
February 15, 2024

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.
February 1, 2024

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.
  • 2020-02-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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