An interventional study of Elemind Neuromodulation (ENMod) in Sleep and Sleep Disturbance, sponsored by Elemind Technologies, Inc.. Completed at 1 site in United States. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by Elemind Technologies, Inc. · Not applicable, Interventional, and Treatment
This study seeks to test whether auditory stimulation delivered at specific phases of the alpha oscillation (as measured by electroencephalogram) can accelerate sleep onset.
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.
324 studies on the registry are indexed under Dyssomnias; 51 are open to participants now.
This study's enrollment of 200 is above the median of 60 across 251 interventional studies indexed under Dyssomnias.
Browse Dyssomnias studies →This is the only study on the registry with Elemind Technologies, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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.
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.
Time frame: At the completion of the study (14 days), including at least 4 days in each block.
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.
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
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.
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
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.
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
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.
Time frame: At the completion of the study (14 days).
Plan to share: No — Individual participant data will not be shared.
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.