Auditory Stimulation for Insomnia and Depression

Feasibility of Using Alpha Phase-Locked Auditory Stimulation for Insomnia Symptoms in People With Depression

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

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia; Depression - Major Depressive Disorder
• Intervention / Treatment: Device: Alpha phase-locked auditory stimulation; Device: Sham Stimulation

Detailed 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 accelerate antidepressant response and reduce suicidal ideation. Insomnia is associated with increased cortical arousal during sleep, reflected by elevated alpha, beta, and theta EEG activity. Although cognitive behavioral therapy for insomnia (CBT-I) and pharmacologic treatments can improve sleep and depression, CBT-I is time-intensive and often inaccessible, while medications pose risks of side effects, dependence, and patient reluctance. Scalable, home-based neuromodulation during sleep represents a promising alternative.

Elemind has developed a closed-loop, audio-driven neurostimulation device that reduces sleep latency by modulating alpha oscillations during pre-sleep quiet wakefulness. The device uses a wearable headband to track sleep stages and deliver precisely timed auditory stimulation to reduce alpha activity and facilitate sleep onset. The auditory stimulation can be applied both at the beginning of the night, and following nighttime awakenings to help reduce sleep onset latency and wake after sleep onset.

After screening and enrolling in the study, participants will wear the headband to sleep nightly for up to 4 weeks, including one week of baseline, one week of either active or sham stimulation, 1 week of washout, and 1 final week of the opposite stimulation condition. Participants will also wear an actigraphy watch and keep a sleep diary throughout the duration of the study. Finally, participants will complete several questionnaires regarding their sleep, mood, and satisfaction with the device throughout the study.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruth Benca, MD, PhD; Phone Number: 336-716-2911; Email: ruth.benca@advocatehealth.org
• Study Contact Backup: Name: Caitlin Carroll, PhD; Phone Number: 336-716-2440; Email: caitlin.carroll@advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27104
      • Wake Forest University Health Sciences
      • Contact: Ruth Benca, MD, PhD; Phone Number: 336-716-2911; Email: ruth.benca@advocatehealth.org
      • Contact: Caitlin Carroll, PhD; Phone Number: 336-716-2440; Email: caitlin.carroll@advocatehealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alpha phase-locked auditory stimulation; participants with symptoms of insomnia and depression	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.; Other Names: Elemind Neuromodulation Device (ENMod)
Sham Comparator: Sham stimulation; participants with symptoms of insomnia and depression	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index	The Insomnia Severity Index (ISI) is a 7-item, self-report questionnaire used to assess the severity, nature, and impact of insomnia over the past two weeks. It measures sleep onset, maintenance, early morning awakening, satisfaction, interference with daily functioning, noticeability to others, and distress. Each item is rated on a 0-4 scale, yielding a total score from 0 to 28 where higher scores indicate more severe insomnia. Generally, a score of 15 or more indicates clinical insomnia.	Baseline, Week 2, Week 4
Epworth Sleepiness Scale (ESS)	The Epworth Sleepiness Scale (ESS) is an 8-item self-administered questionnaire to assess an individual's level of daytime sleepiness. Scores range from 0 to 24, with higher scores indicating greater daytime sleepiness. A score of 10 or higher generally suggests excessive daytime sleepiness, possibly indicating a sleep disorder.	Baseline, Week 2, Week 4
Patient Health Questionnaire (PHQ-9)	9 items with total score range 0-27. Higher scores indicate greater severity of depressive symptoms.	Baseline, Week 2, Week 4
Beck's Depression Inventory (BDI)	The Beck Depression Inventory (BDI) is a 21-item, self-report questionnaire used to measure the severity of depression. It focuses on symptoms like sadness, guilt, and fatigue, with each item rated on a 0-3 scale. Scores range from 0-62, with higher scores indicating more severe depression. Generally, a score of 20 or higher indicates clinical depression.	Baseline, Week 2, Week 4
Subjective Sleep Onset Latency	Sleep onset latency (number of minutes) from baseline to the end of each arm as reported in participant sleep diaries.	Baseline, Week 2, Week 4
Subjective wake after sleep onset	Wake after sleep onset (number of minutes) from baseline to the end of each arm as reported in participant sleep diaries.	Baseline, Week 2, Week 4
Satisfaction Survey	This satisfaction survey is an 11-item self-report questionnaire focusing on ease of device use, impact on sleep, likelihood to continue use, and general satisfaction. Scores for each question range from 1-5, and a cumulative average satisfaction score will be calculated for each participant based on their answers.	Week 2, Week 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generalized Anxiety Disorder (GAD-7)	The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item, self-report questionnaire designed to measure the severity of generalized anxiety, based on symptoms experienced over the last two weeks. Scores range from 0-21, with higher scores indicating increased severity. A score above 10 is generally considered clinical anxiety.	Baseline, Week 2, Week 4
Munich Chronotype Questionnaire (MQCT)	The Munich Chronotype Questionnaire (MQCT) is a 19-item self-report questionnaire designed to assess an individual's chronotype, or preference for sleep-wake times. Total scores can range from 16 to 86, with the lowest values representing extreme-late chronotypes.	Baseline
Hamilton Depression Rating Scale (HAMD-17)	Hamilton Depression Rating Scale (HAMD-17) is a clinician-administered tool designed to evaluate the severity of depressive symptoms in adults. It assesses 17 areas, including mood, guilt, suicide, insomnia, and somatic symptoms. The total score range is 0-52, with higher scores indicating more severe depression.	Baseline, Week 4

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Ruth Benca, MD, PhD, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• Peterson 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.
• 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.
• Bressler 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Depression; sleep; Insomnia
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Behavior; Depression; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: IRB00145704

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No