Auditory Stimulation for Insomnia and Depression (NCT07553364) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Auditory Stimulation for Insomnia and Depression
United States25 participantsStarted 2026-07
Plain-language 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
Who can participate
Age range
20 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.