An observational study in Insomnia, sponsored by Xuanwu Hospital, Beijing. Recruiting at 5 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by Xuanwu Hospital, Beijing · Observational
To establish a multicenter, multi-dimensional cohort on insomnia disorder and to develop an intelligent model for the diagnosis and treatment of insomnia disorder.
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.
1,925 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 612 are open to participants now.
This study's planned enrollment of 16,000 is above the median of 134 across 202 observational studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Xuanwu Hospital, Beijing is the lead sponsor of 357 studies on the registry; 226 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with a complaint about insomnia.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1.A current or history of comorbid Axis I psychiatric disorders.
Patients with a complaint about insomnia.
Other: Routine clinical treatment
Routine clinical treatment is based on the latest international guidelines for insomnia.
The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 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.
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
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.
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.
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The change of Epworth Sleepiness Scale (ESS) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 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.
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The change of sleep onset latency from baseline to 3 months, 6 months, 12 months, 18 months, and 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).
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The change of wake after sleep onset from baseline to 3 months, 6 months, 12 months, 18 months, and 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).
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The change of terminal wakefulness from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.
Terminal wakefulness is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer terminal wakefulness).
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The change of sleep efficiency from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.
Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency).
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The change of total sleep time from baseline to 3 months, 6 months, 12 months, 18 months, and 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).
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The change of time in bed from baseline to 3 months, 6 months, 12 months, 18 months, and 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).
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The change of Insomnia severity index (ISI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 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.
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The change of Short Form 36 (SF-36) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 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).
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The change of PHQ-15 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 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.
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The change of PDQ-D-5 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 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.
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The change of SHAPS total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 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.
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 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.
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2022 (actual). Primary completion is estimated for Oct 2025, 34 months after the start.
Of 76 non-industry observational studies under Sleep Initiation and Maintenance Disorders, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 41. This study's planned 34 months is above that.
Counting every sponsor, half of 83 studies reached it within 22 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sleep Initiation and Maintenance Disorders →