Sounds Locked to ElectroEncephalogram Phase For the Acceleration of Sleep Onset Time (SLEEPFAST)
Sleep, Sleep Disturbance
About this trial
This is an interventional treatment trial for Sleep focused on measuring Neuromodulation, Electroencephalogram, Auditory Stimulation, Sleep, Wake After Sleep Onset
Eligibility Criteria
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
Sites / Locations
- Elemind Technologies, IncRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Sleep Onset Latency Crossover
Wake After Sleep Onset
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.
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).