[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635490":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":60,"collaborators":30,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":30,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":30,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":85,"whyStopped":30,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Alpha phase-locked auditory stimulation","EXPERIMENTAL","participants with symptoms of insomnia and depression",[13],"Device: Alpha phase-locked auditory stimulation",{"label":15,"type":16,"description":11,"interventionNames":17},"Sham stimulation","SHAM_COMPARATOR",[18],"Device: Sham Stimulation",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","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.",[9],[25],"Elemind Neuromodulation Device (ENMod)",{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"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.",[15],null,[32],{"name":33,"affiliation":5,"role":34},"Ruth Benca, MD, PhD","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":30,"email":39},"CONTACT","336-716-2911","ruth.benca@advocatehealth.org",{"name":41,"role":37,"phone":42,"phoneExt":30,"email":43},"Caitlin Carroll, PhD","336-716-2440","caitlin.carroll@advocatehealth.org",[45],{"facility":5,"status":30,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Winston-Salem","North Carolina","27104","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-80.24422,36.09986,{"lat":55,"lon":54},[58,59],{"name":33,"role":37,"phone":38,"phoneExt":30,"email":39},{"name":41,"role":37,"phone":42,"phoneExt":30,"email":43},{"type":61,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100635490","auditory-stimulation-for-insomnia-and-depression-100635490",false,"NCT07553364","Auditory Stimulation for Insomnia and Depression","Feasibility of Using Alpha Phase-Locked Auditory Stimulation for Insomnia Symptoms in People With Depression","Inclusion Criteria:\n\n* Ability to complete overnight EEG study including placement of EEG leads\n* Ability to read and understand English\n* Presence of Insomnia\n* Moderate Depression\n* Home internet and smartphone (Android or Apple) device access\n\nExclusion Criteria:\n\n* Presence of severe, untreated sleep apnea\n* Presence of restless leg syndrome\n* Significant neurological disease (e.g. Parkinson's disease, epilepsy)\n* Diagnosed with schizophrenia, bipolar disorder, substance use disorder, or presence of current suicidal ideation\n* Has active implanted device ( e.g. intracranial device, cochlear implant)\n* Currently deaf or experiencing hearing loss or using hearing aids\n* Currently taking medications that could alter EEG\n* Currently pregnant","ALL","20 Years","50 Years",{"count":73,"type":74},25,"ESTIMATED","INTERVENTIONAL",[77],"NA","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:\n\nDetermine whether alpha phase-locked auditory stimulation (active stimulation) improves objective and subjective sleep in individuals with insomnia and depression.\n\nThe 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.\n\nParticipants will:\n\n* Wear Elemind Neuromod headband nightly for 4 weeks (1 week baseline, 1 week active\u002Fsham stimulation, 1 week washout, and 1 week opposite condition - active\u002Fsham stimulation)\n* Wear actigraphy watch for duration of the study\n* Complete questionnaires regarding their sleep, mood, and satisfaction with the device",[80,81],"Depression - Major Depressive Disorder","Insomnia",[83,84,81],"sleep","Depression","NOT_YET_RECRUITING","2026-06-24",{"date":88,"type":89},"2026-06-26","ACTUAL",{"date":91,"type":74},"2026-07",{"date":93,"type":74},"2027-12-01",{"name":5,"class":6},1]