Non-Invasive, Non-pharmacologic, Computer Interface Approach to Modulate Electroencephalogram (EEG) Potentials, Alertness and Sleep With Acoustic Stimulation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Elemind Technologies, Inc.
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change in Sleep Onset Latency (SOL) from Sham Block Compared to Stimulation Block
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Conditions are blinded to the participant and during data analysis and sleep scoring
Eligibility Criteria
- Ages
- 21 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
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.
Intervention: Elemind Neuromodulation (ENMod) (Device)
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).
Intervention: Elemind Neuromodulation (ENMod) (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Sleep Onset Latency After Wake After Sleep Onset Events (WASO) During Sham Stimulation Sessions Compared to Active Stimulation Sessions(At the completion of the study (7-14 days).)
- Change in Subjective Sleep Onset Latency (SOL) from Sham Block Compared to 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(At the completion of the study (14 days).)
- Change in Sleep Efficiency During Sham Block Compared to Stimulation Block(At the completion of the study (14 days), including at least 4 days in each block.)