InsomniaNCT06375447
Intelligent Diagnosis and Treatment Model for Insomnia Disorder
An observational study of Insomnia, run by Xuanwu Hospital, Beijing at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Routine clinical treatment
- How many people
- 16,000 participants
- Where
- 5 sitesChina
- Study dates
- 1 Dec 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a complaint about insomnia.
Who may be able to join
- 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.
Who cannot join
- 1.A current or history of comorbid Axis I psychiatric disorders.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, 100053
Hongxing Wang, MD & PhD, 01083198650, wanghongxing@xwh.ccmu.edu.cn
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100070
Yi Zhang, MD & PhD, 15801203052, ttyyzy@126.com
- Not yet recruiting
The First Bethune Hospital of Jilin University
Changchun
Zan Wang, MD & PhD
- Recruiting
West China Hospital, Sichuan University
Chengdu, 610041
Lan Zhang, MD & PhD, 18980601706, Zhanglan102@126.com
- Not yet recruiting
The Second Affiliated Hospital of Soochow University
Suzhou
Hua Hu, MD & PhD, 051268282030, sz_huhua@126.com
About this study
Official title: Study on an Intelligent Model for the Diagnosis and Treatment of Insomnia Disorder
To establish a multicenter, multi-dimensional cohort on insomnia disorder and to develop an intelligent model for the diagnosis and treatment of insomnia disorder.
Read the 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.
- Conditions
- Insomnia
- Being tested
- Routine clinical treatment
- Keywords
- Insomnia, Intelligence Model, Prediction, Differential diagnosis and treatment, System
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine clinical treatmentOther
Routine clinical treatment is based on the latest international guidelines for insomnia.
| Study group | Role | What they receive |
|---|---|---|
| Patients with insomnia | Patients with a complaint about insomnia. Receives: Other: Routine clinical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start1 Dec 2022
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, Beijing Tiantan Hospital, Second Affiliated Hospital of Soochow University, Chifeng City Center Hospital Ningcheng County
- Responsible party
- Sponsor
- Investigators
- Hongxing Wang, MD & PhD, Study director, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375447
- Sponsor's protocol ID
- Insomnia
- Status last verified
- Dec 2024
- First submitted
- 1 Jan 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on an Intelligent Model for the Diagnosis and Treatment of Insomnia Disorder
- ClinicalTrials.gov ID
- NCT06375447
- Acronym / sponsor ID
- Insomnia
- Conditions
- Insomnia
- Keywords
- Insomnia, Intelligence Model, Prediction, Differential diagnosis and treatment, System
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 16,000 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- West China Hospital, Beijing Tiantan Hospital, Second Affiliated Hospital of Soochow University, Chifeng City Center Hospital Ningcheng County
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with insomnia | – | Other: Routine clinical treatmentPatients with a complaint about insomnia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a complaint about insomnia.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 1.A current or history of comorbid Axis I psychiatric disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine clinical treatmentRoutine clinical treatment is based on the latest international guidelines for insomnia. | Other | Patients with insomnia |
Primary outcome
The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.
Time frame: 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.
14 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongxing Wang, MD & PhD study director
Xuanwu Hospital, Beijing
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia, run by Xuanwu Hospital, Beijing at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huang Wang, MD (01083198513, wanghuang1118@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.