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Recruiting NCT06375447

Intelligent Diagnosis and Treatment Model for Insomnia Disorder

— Observational Insomnia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Routine clinical treatment.
Who it may be relevant to
Registry conditions: Insomnia. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 5 centers
  • Xuanwu Hospital, Capital Medical University — Beijing
  • Beijing Tiantan Hospital, Capital Medical University — Beijing
  • The First Bethune Hospital of Jilin University — Changchun
  • West China Hospital, Sichuan University — Chengdu
  • The Second Affiliated Hospital of Soochow University — Suzhou

Identifiers

NCT: NCT06375447 · Insomnia

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗