Intelligent Diagnosis and Treatment Model for Insomnia Disorder

Insomnia Clinical Trial

Official title:

Study on an Intelligent Model for the Diagnosis and Treatment of Insomnia Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06375447
• Other study ID #: Insomnia
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Xuanwu Hospital, Beijing
• Contact: Huang Wang, MD
• Phone: 01083198513
• Email: wanghuang1118[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 16000
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. A complaint of insomnia;

2. Age between 18 and 75;

3. Able to fill out the scale on their own;

4. Agree to sign the informed consent to participate in the study and cooperate in completing the follow-up visit.

Exclusion Criteria:

1.A current or history of comorbid Axis I psychiatric disorders.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Other:
• Routine clinical treatment
Routine clinical treatment is based on the latest international guidelines for insomnia.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing
China	Xuanwu Hospital, Capital Medical University	Beijing
China	The First Bethune Hospital of Jilin University	Changchun
China	West China Hospital, Sichuan University	Chengdu
China	The Second Affiliated Hospital of Soochow University	Suzhou

Sponsors (5)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing	Beijing Tiantan Hospital, Ningcheng Center Hospital, Second Affiliated Hospital of Soochow University, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Secondary	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.	Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Secondary	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.	Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Secondary	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).	Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Secondary	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).	Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Secondary	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).	Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Secondary	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).	Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Secondary	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).	Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Secondary	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).	Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Secondary	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.	Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Secondary	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).	Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Secondary	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.	Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Secondary	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.	Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Secondary	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.	Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Secondary	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.	Baseline, 3 months, 6 months, 12 months, 18 months, 24 months