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Recruiting
NCT05743114
Sounds Locked to ElectroEncephalogram Phase For the Acceleration of Sleep Onset Time
Conditions: Sleep, Sleep Disturbance
Sex: All
Ages: 21 Years – 55 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 250
Sponsor: Elemind Technologies, Inc.
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:Able to provide informed consent after reading and answering questions in written EnglishSelf-report that it takes 30 minutes on average or more to fall asleepSubthreshold 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 medicationsSelf-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 weekExclusion Criteria:Unable to read or understand EnglishBody Mass Index (weight/height ratio) >33Self-report of being diagnosed with apneaCurrent or past history of a neurological disorder or psychiatric illnessSelf-report that it takes less than 30 minutes to fall asleep on averageSevere 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 medicationsConsumption of more than 4 cups of Caffeinated beverages per dayAny caffeine < 6hrs prior to each recording session (e.g.
coffee, tea, caffeinated sodas etc.)Any seizures or family history of seizuresHistory of migraineHistory of brain related injury or unexplained loss of consciousnessCardiac pacemaker or intracranial metal implantPregnantTaking any anti-depressants, stimulants, medication for hypertension or hypotension and/or cannabis derived productsCochlear implant in either earDiagnosed with hearing impairment or deafnessWorks night shifts any night of the week
Source: ClinicalTrials.gov (NCT05743114). StuddyBuddy aggregates publicly available trial information.