protocolSection identificationModule nctId: NCT06375447, orgStudyIdInfo id: Insomnia, briefTitle: Intelligent Diagnosis and Treatment Model for Insomnia Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-01, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Xuanwu Hospital, Beijing, class: OTHER, collaborators name: West China Hospital, collaborators name: Beijing Tiantan Hospital, collaborators name: Ningcheng Center Hospital, collaborators name: Second Affiliated Hospital of Soochow University, descriptionModule briefSummary: To establish a multicenter, multi-dimensional cohort on insomnia disorder and to develop an intelligent model for the diagnosis and treatment of insomnia disorder., conditionsModule conditions: Insomnia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 16000, type: ESTIMATED, armsInterventionsModule interventions name: Routine clinical treatment, outcomesModule primaryOutcomes measure: The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of Epworth Sleepiness Scale (ESS) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of sleep onset latency from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of wake after sleep onset from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of terminal wakefulness from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of sleep efficiency from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of total sleep time from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of time in bed from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of Insomnia severity index (ISI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of Short Form 36 (SF-36) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of PHQ-15 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of PDQ-D-5 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of SHAPS total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xuanwu Hospital, Capital Medical University, status: RECRUITING, city: Beijing, zip: 100053, country: China, contacts name: Hongxing Wang, MD & PhD, role: CONTACT, phone: 01083198650, email: wanghongxing@xwh.ccmu.edu.cn, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Tiantan Hospital, Capital Medical University, status: RECRUITING, city: Beijing, zip: 100070, country: China, contacts name: Yi Zhang, MD & PhD, role: CONTACT, phone: 15801203052, email: ttyyzy@126.com, geoPoint lat: 39.9075, lon: 116.39723, locations facility: The First Bethune Hospital of Jilin University, status: NOT_YET_RECRUITING, city: Changchun, country: China, contacts name: Zan Wang, MD & PhD, role: CONTACT, geoPoint lat: 43.88, lon: 125.32278, locations facility: West China Hospital, Sichuan University, status: RECRUITING, city: Chengdu, zip: 610041, country: China, contacts name: Lan Zhang, MD & PhD, role: CONTACT, phone: 18980601706, email: Zhanglan102@126.com, geoPoint lat: 30.66667, lon: 104.06667, locations facility: The Second Affiliated Hospital of Soochow University, status: NOT_YET_RECRUITING, city: Suzhou, country: China, contacts name: Hua Hu, MD & PhD, role: CONTACT, phone: 051268282030, email: sz_huhua@126.com, geoPoint lat: 31.30408, lon: 120.59538, hasResults: False