Auditory Stimulation for Insomnia and Depression

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT07553364
Status
Not Yet Recruiting

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Conditions

  • Depression - Major Depressive Disorder
  • Insomnia

Eligibility Criteria

Sex
ALL
Age
20 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Alpha phase-locked auditory stimulation — DEVICE
    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.
  • Sham Stimulation — DEVICE
    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.

Study Details

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

Key Dates

Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Jun 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Alpha phase-locked auditory stimulation
    participants with symptoms of insomnia and depression
  • Sham Comparator: Sham stimulation
    participants with symptoms of insomnia and depression

Primary Outcome Measure

Sleep Onset Latency - Measurement 1 [ Time Frame: from baseline to week 2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27104
Ruth Benca, MD, PhD
[email protected]
336-716-2911
Caitlin Carroll, PhD
[email protected]
336-716-2440

Find similar trials in Winston-Salem, NC

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
Wake Forest University Health Sciences· Winston-Salem, NC

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