SleepSLEEPFASTNCT05743114
Sounds Locked to ElectroEncephalogram Phase For the Acceleration of Sleep Onset Time
A study testing Elemind Neuromodulation (ENMod) in people with Sleep and Sleep Disturbance, run by Elemind Technologies, Inc. at 1 site in United States.
Trial summary
This study seeks to test whether auditory stimulation delivered at specific phases of the alpha oscillation (as measured by electroencephalogram) can accelerate sleep onset. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Sleep Disturbance
- What is being tested?
- Elemind Neuromodulation (ENMod)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2020to 10 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Elemind Technologies, Inc
Cambridge, Massachusetts, 02139
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep, Sleep Disturbance
- Being tested
- Elemind Neuromodulation (ENMod)
- Keywords
- Neuromodulation, Electroencephalogram, Auditory Stimulation, Sleep, Wake After Sleep Onset
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elemind Neuromodulation (ENMod)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Onset Latency Crossover | Experimental | 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. Receives: Device: Elemind Neuromodulation (ENMod) |
| Wake After Sleep Onset | Experimental | 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). Receives: Device: Elemind Neuromodulation (ENMod) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sleep Onset Latency (SOL) from Sham Block Compared to Stimulation 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.
Measured: At the completion of the study (14 days), including at least 4 days in each block.
Secondary outcomes (4)
Change in Sleep Efficiency During Sham Block Compared to Stimulation 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.
Measured: 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
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.
Measured: At the completion of the study (7-14 days).
Change in Subjective Sleep Onset Latency (SOL) from Sham Block Compared to Stimulation Block
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.
Measured: At the completion of the study (14 days).
Change in Subjective Daytime Sleepiness (Karolinska Sleepiness Scale) from Sham Block Compared to Stimulation Block
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.
Measured: At the completion of the study (14 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start2 Feb 2020
- Primary completion15 Nov 2023
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elemind Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743114
- Sponsor's protocol ID
- 2020-02-13
- Acronym
- SLEEPFAST
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Publications
Bressler S, Neely R, Yost RM, Wang D. A randomized controlled trial of alpha phase-locked auditory stimulation to treat symptoms of sleep onset insomnia. Sci Rep. 2024 Jun 6;14(1):13039. doi: 10.1038/s41598-024-63385-1.
PubMed 38844793
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive, Non-pharmacologic, Computer Interface Approach to Modulate Electroencephalogram (EEG) Potentials, Alertness and Sleep With Acoustic Stimulation
- ClinicalTrials.gov ID
- NCT05743114
- Acronym / sponsor ID
- SLEEPFAST / 2020-02-13
- Conditions
- Sleep, Sleep Disturbance
- Keywords
- Neuromodulation, Electroencephalogram, Auditory Stimulation, Sleep, Wake After Sleep Onset
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Elemind Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2020 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to test whether auditory stimulation delivered at specific phases of the alpha oscillation (as measured by electroencephalogram) can accelerate sleep onset.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Onset Latency Crossover | Experimental | Device: Elemind Neuromodulation (ENMod)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. |
| Wake After Sleep Onset | Experimental | Device: Elemind Neuromodulation (ENMod)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). |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Sleep Onset Latency Crossover, Wake After Sleep Onset |
Primary outcome
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.
4 secondary outcomes
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 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).
Change in Subjective Sleep Onset Latency (SOL) from Sham Block Compared to Stimulation Block
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 38844793Bressler S, Neely R, Yost RM, Wang D. A randomized controlled trial of alpha phase-locked auditory stimulation to treat symptoms of sleep onset insomnia. Sci Rep. 2024 Jun 6;14(1):13039. doi: 10.1038/s41598-024-63385-1.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elemind Neuromodulation (ENMod) in people with Sleep and Sleep Disturbance, run by Elemind Technologies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05743114, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.