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Auditory Stimulation for Insomnia and Depression

Reason given: unable to obtain equipment needed for study

Key facts

Where
Winston-Salem, United StatesSee the site

Where in United States

  • Wake Forest University Health SciencesWinston-Salem, United StatesNo longer taking part

Trial details

Who runs it
Wake Forest University Health Sciences
Trial code
NCT07553364
Record updated
27 August 2026
Original description
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:Read full original descriptionShow less

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

Inclusion: 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: Has active implanted device ( e.g. intracranial device, cochlear implant); Currently taking medications that could alter EEG; 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; Presence of severe, untreated sleep apnea; Currently deaf or experiencing hearing loss or using hearing aids; Currently pregnant.

ClinicalTrials.gov NCT07553364