Intelligent Diagnosis and Treatment Model for Insomnia Disorder
- Conditions
- Insomnia
- Interventions
- Other: Routine clinical treatment
- Registration Number
- NCT06375447
- Lead Sponsor
- Xuanwu Hospital, Beijing
- Brief Summary
To establish a multicenter, multi-dimensional cohort on insomnia disorder and to develop an intelligent model for the diagnosis and treatment of insomnia disorder.
- Detailed Description
The study endeavors to establish a multicenter cohort comprising 16,000 individuals diagnosed with insomnia disorder, with a subsequent 2-year follow-up. Objectives encompass elucidating the natural development of insomnia disorder within diverse populations, identifying associated factors, and evaluating the short-term and long-term impacts on physiological, psychological, and social functions in insomnia disorder. Additionally, the research aims to devise early screening methodologies, precise assessments, and innovative disease classifications utilizing real-time assessment technology within the insomnia disorder cohort. Furthermore, the investigation seeks to ascertain graded diagnoses, treatment modalities, and prognostic indicators based on advanced multi-dimensional real-time assessment technology applied to a substantial insomnia disorder cohort. Finally, the study aims to refine remote interactive diagnostic and treatment modalities tailored to diverse age groups, culminating in developing a systematic graded diagnostic and treatment framework for insomnia disorder.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 16000
- A complaint of insomnia;
- Age between 18 and 75;
- Able to fill out the scale on their own;
- Agree to sign the informed consent to participate in the study and cooperate in completing the follow-up visit.
1.A current or history of comorbid Axis I psychiatric disorders.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with insomnia Routine clinical treatment Patients with a complaint about insomnia.
- Primary Outcome Measures
Name Time Method The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. Baseline, 3 months, 6 months, 12 months, 18 months, 24 months The PSQI consists of 7 factors ranging from 0 to 3 points, and the total score ranges from 0 to 21 with higher scores indicating poorer quality.
- Secondary Outcome Measures
Name Time Method The change of Epworth Sleepiness Scale (ESS) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. Baseline, 3 months, 6 months, 12 months, 18 months, 24 months The ESS assessing daytime sleepiness consists of 8-items on a 4-point Likert scale, and the total score ranges from 0 to 24 with higher scores indicating more sleepiness.
The change of PHQ-15 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. Baseline, 3 months, 6 months, 12 months, 18 months, 24 months The PHQ-15 measuring somatic distress consists of 15 items, and the total score ranges from 0 to 30 with higher scores indicating more severe somatic distress.
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. Baseline, 3 months, 6 months, 12 months, 18 months, 24 months The DBAS assessing sleep related cognitions in 16 item rated on a 10-point Likert scale, and the total score ranges from 0 to 160 with higher scores indicating more intensive disfunctional beliefs.
The change of PDQ-D-5 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. Baseline, 3 months, 6 months, 12 months, 18 months, 24 months The PDQ-D-5 assessing perceived cognitive deficits from the patient's perspective consists of 5 items, and the total score ranges from 0 to 20 with higher scores indicating greater perceived deficit.
The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. Baseline, 3 months, 6 months, 12 months, 18 months, 24 months The LES assessing the perceived stress and number of stressful life events experienced consists of 48 items which are classified into three dimensions: family life events (28 items), work and study events (13 items), and social events (7 items) with higher scores in LES perceived greater stressfulness.
The change of sleep onset latency from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. Baseline, 3 months, 6 months, 12 months, 18 months, 24 months Sleep onset latency is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer sleep onset latency).
The change of total sleep time from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. Baseline, 3 months, 6 months, 12 months, 18 months, 24 months Total sleep time is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer total sleep time).
The change of time in bed from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. Baseline, 3 months, 6 months, 12 months, 18 months, 24 months Time in bed is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer time in bed).
The change of Short Form 36 (SF-36) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. Baseline, 3 months, 6 months, 12 months, 18 months, 24 months The SF-36 quantifing the quality of life in relation to health status consists of 36-items with eight areas covering physical functioning, role limitations brought on by physical issues, bodily pain, general health perceptions, vitality, social functioning, role limitations brought on by emotional issues, and perceived mental health. The total score ranges from 0-100 (the worst possible to the most possible).
The change of Insomnia severity index (ISI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. Baseline, 3 months, 6 months, 12 months, 18 months, 24 months The ISI reporting insomnia symptoms severity consists of 7-items on a 5-point Likert scale, and the total score ranges from 0 to 28 with higher scores indicating more severe insomnia.
The change of SHAPS total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. Baseline, 3 months, 6 months, 12 months, 18 months, 24 months The SHAPS assessing anhedonia consists of 14 items, and the total score ranges from 14 to 56 with higher scores indicating more serious the anhedonia.
The change of wake after sleep onset from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. Baseline, 3 months, 6 months, 12 months, 18 months, 24 months Wake after sleep onset is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer wake after sleep onset).
The change of terminal wakefulness from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. Baseline, 3 months, 6 months, 12 months, 18 months, 24 months Terminal wakefulness is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer terminal wakefulness).
The change of sleep efficiency from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. Baseline, 3 months, 6 months, 12 months, 18 months, 24 months Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency).
Trial Locations
- Locations (5)
Xuanwu Hospital, Capital Medical University
🇨🇳Beijing, China
Beijing Tiantan Hospital, Capital Medical University
🇨🇳Beijing, China
The First Bethune Hospital of Jilin University
🇨🇳Changchun, China
The Second Affiliated Hospital of Soochow University
🇨🇳Suzhou, China
West China Hospital, Sichuan University
🇨🇳Chengdu, China