Auditory Stimulation for Insomnia and Depression
Feasibility of Using Alpha Phase-Locked Auditory Stimulation for Insomnia Symptoms in People With Depression
1 other identifier
interventional
25
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2026
CompletedFirst Posted
Study publicly available on registry
April 28, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
Study Completion
Last participant's last visit for all outcomes
December 1, 2027
May 4, 2026
April 1, 2026
1 year
April 21, 2026
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Sleep Onset Latency - Measurement 1
Change in sleep onset latency (number of minutes) recorded using ENMod
from baseline to week 2
Wake after sleep onset - Measurement 1
Change in wake after sleep onset (number of minutes) recorded using ENMod
from baseline to week 2
Sleep Onset Latency - Measurement 2
Change in sleep onset latency (number of minutes) recorded using ENMod
from baseline to week 4
Wake after sleep onset - Measurement 2
Change in wake after sleep onset (number of minutes) recorded using ENMod
from baseline to week 4
Secondary Outcomes (7)
Insomnia Severity Index
Baseline, Week 2, Week 4
Epworth Sleepiness Scale (ESS)
Baseline, Week 2, Week 4
Patient Health Questionnaire (PHQ-9)
Baseline, Week 2, Week 4
Beck's Depression Inventory (BDI)
Baseline, Week 2, Week 4
Satisfaction Survey
Week 2, Week 4
- +2 more secondary outcomes
Other Outcomes (3)
Generalized Anxiety Disorder (GAD-7)
Baseline, Week 2, Week 4
Munich Chronotype Questionnaire (MQCT)
Baseline
Hamilton Depression Rating Scale (HAMD-17)
Baseline, Week 4
Study Arms (2)
Alpha phase-locked auditory stimulation
EXPERIMENTALparticipants with symptoms of insomnia and depression
Sham stimulation
SHAM COMPARATORparticipants with symptoms of insomnia and depression
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27104, United States
Related Publications (3)
Bressler S, Neely R, Yost RM, Wang D, Read HL. A wearable EEG system for closed-loop neuromodulation of sleep-related oscillations. J Neural Eng. 2023 Oct 5;20(5). doi: 10.1088/1741-2552/acfb3b.
PMID: 37726002BACKGROUNDPeterson MJ, Benca RM. Sleep in mood disorders. Psychiatr Clin North Am. 2006 Dec;29(4):1009-32; abstract ix. doi: 10.1016/j.psc.2006.09.003.
PMID: 17118279BACKGROUNDBressler S, Neely R, Yost RM, Wang D. Author Correction: A randomized controlled trial of alpha phase-locked auditory stimulation to treat symptoms of sleep onset insomnia. Sci Rep. 2024 Sep 19;14(1):21867. doi: 10.1038/s41598-024-72802-4. No abstract available.
PMID: 39300282BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruth Benca, MD, PhD
Wake Forest University Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2026
First Posted
April 28, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share