Intelligent Diagnosis and Treatment Model for Insomnia Disorder

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.

Study Overview

• Status: Recruiting
• Conditions: Insomnia
• Intervention / Treatment: Other: Routine clinical treatment

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 Type: Observational
• Enrollment (Estimated): 16000

Contacts and Locations

• Study Contact: Name: Huang Wang, MD; Phone Number: 01083198513; Email: wanghuang1118@163.com

Study Locations

• China
  • Beijing, China, 100053
    • Recruiting
    • Xuanwu Hospital, Capital Medical University
    • Contact: Hongxing Wang, MD & PhD; Phone Number: 01083198650; Email: wanghongxing@xwh.ccmu.edu.cn
  • Beijing, China, 100070
    • Recruiting
    • Beijing Tiantan Hospital, Capital Medical University
    • Contact: Yi Zhang, MD & PhD; Phone Number: 15801203052; Email: ttyyzy@126.com
  • Changchun, China
    • Not yet recruiting
    • The First Bethune Hospital of Jilin University
    • Contact: Zan Wang, MD & PhD
  • Chengdu, China, 610041
    • Recruiting
    • West China Hospital, Sichuan University
    • Contact: Lan Zhang, MD & PhD; Phone Number: 18980601706; Email: Zhanglan102@126.com
  • Suzhou, China
    • Not yet recruiting
    • The Second Affiliated Hospital of Soochow University
    • Contact: Hua Hu, MD & PhD; Phone Number: 051268282030; Email: sz_huhua@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a complaint about insomnia.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with insomnia; Patients with a complaint about insomnia.	Other: Routine clinical treatment; Routine clinical treatment is based on the latest international guidelines for insomnia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: Beijing Tiantan Hospital; West China Hospital; Second Affiliated Hospital of Soochow University; Chifeng City Center Hospital Ningcheng County
• Investigators: Study Director: Hongxing Wang, MD & PhD, Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 1, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Insomnia; Prediction; System; Intelligence Model; Differential diagnosis and treatment
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: insomnia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No