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Auditory Stimulation for Insomnia and Depression

NCT07553364 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-05-04

No results posted yet for this study

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

Conditions

  • Depression - Major Depressive Disorder
  • Insomnia

Interventions

DEVICE

Alpha 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.

DEVICE

Sham 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.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Ruth Benca, MD, PhD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-06-01
Completion
2027-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07553364 on ClinicalTrials.gov