NCT06375447

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 1, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

2.9 years

First QC Date

January 1, 2024

Last Update Submit

December 4, 2024

Conditions

Insomnia

Keywords

InsomniaIntelligence ModelPredictionDifferential diagnosis and treatmentSystem

Outcome Measures

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.

    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 Outcomes (14)

  • 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.

    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.

    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.

    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.

    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.

    Baseline, 3 months, 6 months, 12 months, 18 months, 24 months

  • +9 more secondary outcomes

Study Arms (1)

Patients with insomnia

Patients with a complaint about insomnia.

Other: Routine clinical treatment

Interventions

Routine clinical treatmentOTHER

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

Patients with insomnia

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a complaint about insomnia.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

RECRUITING

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100070, China

RECRUITING

The First Bethune Hospital of Jilin University

Changchun, China

NOT YET RECRUITING

West China Hospital, Sichuan University

Chengdu, 610041, China

RECRUITING

The Second Affiliated Hospital of Soochow University

Suzhou, China

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be collected. The buffy coat of blood collected in an EDTA-tube to obtain plasma, will be stored for the isolation of DNA.

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Hongxing Wang, MD & PhD

    Xuanwu Hospital, Beijing

    STUDY DIRECTOR

Central Study Contacts

Huang Wang, MD

CONTACT

01083198513wanghuang1118@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2024

First Posted

April 19, 2024

Study Start

December 1, 2022

Primary Completion

October 31, 2025

Study Completion

December 31, 2025

Last Updated

December 10, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(5)