Clinical trial NCT06375447: Intelligent Diagnosis and Treatment Model for Insomnia Disorder
Official title: Study on an Intelligent Model for the Diagnosis and Treatment of Insomnia Disorder
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Insomnia
Keywords: Insomnia
Intelligence Model
Prediction
Differential diagnosis and treatment
System
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: West China Hospital
name: Beijing Tiantan Hospital
name: Second Affiliated Hospital of Soochow University
name: Chifeng City Center Hospital Ningcheng County
First posted: 2024-04-19
Enrollment: 16000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a complaint about insomnia.

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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Secondary outcomes:
measure: 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.
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
measure: The change of Epworth Sleepiness Scale (ESS) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
measure: The change of sleep onset latency from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
measure: The change of wake after sleep onset from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
measure: The change of terminal wakefulness from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
measure: The change of sleep efficiency from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
measure: The change of total sleep time from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
measure: The change of time in bed from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
measure: The change of Insomnia severity index (ISI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
measure: The change of Short Form 36 (SF-36) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
measure: The change of PHQ-15 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
measure: The change of PDQ-D-5 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
measure: The change of SHAPS total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
measure: The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Hongxing Wang, MD & PhD
role: STUDY_DIRECTOR
References: