Depression - Major Depressive DisorderNCT07553364
Auditory Stimulation for Insomnia and Depression
A study testing Alpha phase-locked auditory stimulation in people with Depression - Major Depressive Disorder and Insomnia, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Depression - Major Depressive Disorder, Insomnia
- What is being tested?
- Alpha phase-locked auditory stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27104
About this study
Official title: 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.
Read more
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
Read the 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.
- Conditions
- Depression - Major Depressive Disorder, Insomnia
- Being tested
- Alpha phase-locked auditory stimulation, Sham Stimulation
- Keywords
- sleep, Depression, Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha phase-locked auditory stimulationDevice
Also called Elemind Neuromodulation Device (ENMod)
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 StimulationDevice
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 group | Role | What they receive |
|---|---|---|
| Alpha phase-locked auditory stimulation | Experimental | participants with symptoms of insomnia and depression Receives: Device: Alpha phase-locked auditory stimulation |
| Sham stimulation | Sham comparator | participants with symptoms of insomnia and depression Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Onset Latency - Measurement 1
Change in sleep onset latency (number of minutes) recorded using ENMod
Measured: from baseline to week 2
Wake after sleep onset - Measurement 1
Change in wake after sleep onset (number of minutes) recorded using ENMod
Measured: from baseline to week 2
Sleep Onset Latency - Measurement 2
Change in sleep onset latency (number of minutes) recorded using ENMod
Measured: from baseline to week 4
Wake after sleep onset - Measurement 2
Change in wake after sleep onset (number of minutes) recorded using ENMod
Measured: from baseline to week 4
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 2, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study startAug 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Why it stopped: unable to obtain equipment needed for study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruth Benca, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553364
- Sponsor's protocol ID
- IRB00145704
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37726002Peterson 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.
PubMed 17118279Bressler 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.
PubMed 39300282
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Using Alpha Phase-Locked Auditory Stimulation for Insomnia Symptoms in People With Depression
- ClinicalTrials.gov ID
- NCT07553364
- Acronym / sponsor ID
- IRB00145704
- Conditions
- Depression - Major Depressive Disorder, Insomnia
- Keywords
- sleep, Depression, Insomnia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to obtain equipment needed for study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alpha phase-locked auditory stimulation | Experimental | Device: Alpha phase-locked auditory stimulationparticipants with symptoms of insomnia and depression |
| Sham stimulation | Sham comparator | Device: Sham Stimulationparticipants with symptoms of insomnia and depression |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha phase-locked auditory stimulationAlso: Elemind Neuromodulation Device (ENMod)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 | Alpha phase-locked auditory stimulation |
| Sham StimulationUsing 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. | Device | Sham stimulation |
Primary outcome
Sleep Onset Latency - Measurement 1
Time frame: from baseline to week 2
Change in sleep onset latency (number of minutes) recorded using ENMod
Wake after sleep onset - Measurement 1
Time frame: from baseline to week 2
Change in wake after sleep onset (number of minutes) recorded using ENMod
Sleep Onset Latency - Measurement 2
Time frame: from baseline to week 4
Change in sleep onset latency (number of minutes) recorded using ENMod
Wake after sleep onset - Measurement 2
Time frame: from baseline to week 4
Change in wake after sleep onset (number of minutes) recorded using ENMod
7 secondary outcomes
Insomnia Severity Index
Time frame: Baseline, Week 2, Week 4
Epworth Sleepiness Scale (ESS)
Time frame: Baseline, Week 2, Week 4
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, Week 2, Week 4
Beck's Depression Inventory (BDI)
Time frame: Baseline, Week 2, Week 4
Satisfaction Survey
Time frame: Week 2, Week 4
Subjective Sleep Onset Latency
Time frame: Baseline, Week 2, Week 4
Subjective wake after sleep onset
Time frame: Baseline, Week 2, Week 4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Background: PubMed 37726002Bressler 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.
- Background: PubMed 17118279Peterson 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.
- Background: PubMed 39300282Bressler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Benca, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha phase-locked auditory stimulation in people with Depression - Major Depressive Disorder and Insomnia, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Onset Latency - Measurement 1 (time frame: from baseline to week 2). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07553364, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.