[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562518":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":52,"collaborators":11,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":11,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":11,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":11,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Chang Gung Memorial Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Binaural Beats","EXPERIMENTAL",null,[13],"Device: Binaural Beats",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","SHAM_COMPARATOR",[18],"Device: Placebo",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DEVICE","The binaural beat device is a health product that is not classified as a medical device. It functions similarly to a music box, providing different frequencies through physiological and psychological induction. This process offers binaural beat information to the Reticular Activating System (RAS) for potential changes in consciousness. The binaural beat frequencies are designed to match the brainwave frequency of light sleep, specifically 3.4 Hz (θ waves), with a base frequency of 440 Hz. The device uses three types of background music-piano music, light music, and string music-as experimental materials.\n\nThe binaural beat device offers three modes, allowing users to select different modes based on their comfort and listening preferences. This study requires that the binaural beats be listened to for at least 30 minutes. The device has a built-in app for continuous playback, so users can connect the power and listen throughout the night.",[9],{"type":21,"name":15,"description":15,"armGroupLabels":25,"otherNames":11},[15],[27],{"name":28,"affiliation":5,"role":29},"Yu-Shu Huang, MD, PhD","STUDY_CHAIR",[31],{"name":32,"role":33,"phone":34,"phoneExt":11,"email":35},"Yi-Min Fang, MD","CONTACT","+886931776313","butterlion721@gmail.com",[37],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":40,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Taoyuan","Taiwan","333","TW",{"type":44,"coordinates":45},"Point",[46,47],121.29696,24.99368,{"lat":47,"lon":46},[50],{"name":32,"role":33,"phone":51,"phoneExt":11,"email":35},"886931776313",{"type":53,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100562518","improvement-of-sleep-quality-of-insomnia-patients-with-binaural-beats-100562518",false,"NCT06604208","Improvement of Sleep Quality of Insomnia Patients with \"Binaural Beats\"","Double-blind, Randomized, Placebo-controlled Trial to Explore the Improvement of Sleep Quality of Insomnia Patients with \"Binaural Beats\"","Inclusion Criteria:\n\n* Gender: No restrictions, Age: Between 20 and 75 years.\n* Meets the criteria for insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5):\n\n  1. Difficulty sleeping and insomnia occurring at least 3 nights per week.\n  2. Insomnia and sleep difficulties persisting for at least 3 months.\n* The participant has signed the informed consent form.\n\nExclusion Criteria:\n\n* Individuals who are unable to complete the consent form, undergo testing, and attend regular follow-up visits as required by the study.\n* Individuals with severe physical illnesses or post-surgical conditions, such as heart disease or metabolic disorders.\n* Individuals with severe psychiatric disorders, including schizophrenia, major depressive disorder, severe anxiety disorder, bipolar disorder, dementia, or substance use disorders; or severe neurological conditions, such as stroke or epilepsy.\n* Individuals with other severe sleep disorders, such as severe sleep apnea.\n* Individuals who are unable to maintain a stable medication dosage during the trial period, particularly with ongoing treatments.\n* Patients deemed unsuitable for participation in the trial by the principal investigator.\n* Patients who are unable to adhere to sleep hygiene practices or who cannot refrain from using electronic devices before bedtime.","ALL","20 Years","75 Years",{"count":65,"type":66},74,"ESTIMATED","INTERVENTIONAL",[69],"NA","The goal of this clinical trial is to learn if binaural beat works to treat chronic insomnia in adults. It will also learn about the safety of binaural beat. The main questions it aims to answer are:\n\nWhat medical problems do participants have when using binaural beat? Researchers will compare binaural beat to a placebo to see if binaural beat works to treat chronic insomnia.\n\nParticipants will:\n\nUsing binaural beat or a placebo every day for 2 weeks Keep a diary and actigraphy of their insomnia symptoms Visit the clinic after 2 weeks testing for checkups and tests",[72],"Insomnia Chronic","2025-02-12",{"date":75,"type":76},"2025-02-14","ACTUAL",{"date":78,"type":76},"2024-12-27",{"date":80,"type":66},"2025-08-31",{"name":5,"class":6},1]