Feasibility of Using Alpha Phase-Locked Auditory Stimulation for Insomnia Symptoms in People With Depression
Wake Forest University Health Sciences
Summary
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
Description
The purpose of this pilot study is to determine if non-invasive alpha-phase locked auditory stimulation delivered before sleep can improve objective and subjective sleep outcomes in individuals with depression and insomnia. Moreover, the study team will determine if this protocol design is feasible and acceptable to this population to inform the design of a larger scale clinical trial in this population. Insomnia is highly prevalent among individuals with major depressive disorder (MDD) and is a strong risk factor for onset and recurrence. Effective treatment of insomnia has been shown to acc…
Eligibility
- Age range
- 20–50 years
- Sex
- All
- Healthy volunteers
- No
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, cochlea…
Interventions
- DeviceAlpha phase-locked auditory stimulation
Using the ENMod device, participants will receive alpha phase-locked auditory stimulation delivered as pink noise pulses through a bone conduction driver placed near the middle of the forehead. To mask the sound of the stimulation, natural rain sounds will be played alongside the pink noise.
- DeviceSham Stimulation
Using the ENMod device, participants will receive sham stimulation, which is presented as natural rain sounds alone, through a bone conduction driver placed near the middle of the forehead.
Location
- Wake Forest University Health SciencesWinston-Salem, North Carolina