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Sponsor: Wake Forest University Health Sciences
Conditions: Depression - Major Depressive Disorder, Insomnia
Interventions: Alpha phase-locked auditory stimulation, Sham Stimulation
Countries: United States
The goal of this clinical trial is to determine if alpha phase-locked auditory stimulation can improve sleep in people with insomnia and depression. The main goals of the pilot study are the following: Determine whether alpha phase-locked auditory stimulation (active stimulation) improves objective and subjective sleep in individuals with insomnia and depression. The study team hypothesizes that active auditory stimulation will reduce objective and subjective sleep onset latency (SL) and wake after sleep onset (WASO) compared to a sham stimulation. Participants will: * Wear Elemind Neuromod headband nightly for 4 weeks (1 week baseline, 1 week active/sham stimulation, 1 week washout, and 1 week opposite condition - active/sham stimulation) * Wear actigraphy watch for duration of the study * Complete questionnaires regarding their sleep, mood, and satisfaction with the device
Sex: ALL
Age: 20 Years to 50 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Ability to complete overnight EEG study including placement of EEG leads * Ability to read and understand English * Presence of Insomnia * Moderate Depression * Home internet and smartphone (Android or Apple) device access Exclusion Criteria: * Presence of severe, untreated sleep apnea * Presence of restless leg syndrome * Significant neurological disease (e.g. Parkinson's disease, epilepsy) * Diagnosed with schizophrenia, bipolar disorder, substance use disorder, or presence of current suicidal ideation * Has active implanted device ( e.g. intracranial device, cochlear implant) * Currently deaf or experiencing hearing loss or using hearing aids * Currently taking medications that could alter EEG * Currently pregnant
- Winston-Salem, North Carolina, United States