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NCT Number: NCT06375447

Intelligent Diagnosis and Treatment Model for 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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tiantan Hospital, Capital Medical University, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Routine clinical treatment

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 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.

  2. 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 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.

  3. 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

    Sleep onset latency is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer sleep onset latency).

  4. 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

    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).

  5. 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

    Terminal wakefulness is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer terminal wakefulness).

  6. 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

    Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency).

  7. 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

    Total sleep time is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer total sleep time).

  8. 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

    Time in bed is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer time in bed).

  9. 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 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.

  10. 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 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).

  11. 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 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.

  12. 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 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.

  13. 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 SHAPS assessing anhedonia consists of 14 items, and the total score ranges from 14 to 56 with higher scores indicating more serious the anhedonia.

  14. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Huang Wang, MD

CONTACT

[email protected]

01083198513

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Collaborators

  • Beijing Tiantan Hospital
  • Chifeng City Center Hospital Ningcheng County
  • Second Affiliated Hospital of Soochow University
  • West China Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 19, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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