Evaluating the Effectiveness of Intervention Based on the Model of Occupational Harmony in Patients With Sleep Disorders

Not Applicable

Active, not recruiting

• Conditions: Circadian Rhythm Sleep-Wake Disorder

• Registration Number: NCT06558929
• Lead Sponsor: Peking University First Hospital

Brief Summary

The goal of this clinical trial is to learn the effectiveness of an intervention based on the Model of Occupational Harmony (MOHar) in treating patients with sleep disorders. The main questions it aims to answer are:

* Does intervention based on the MOHar improve sleep quality in patients with sleep disorders?

* Does intervention based on the MOHar improve the quality of life in patients with sleep disorders?

Researchers will compare the intervention based on the MOHar to conventional treatment to see if the intervention works to treat sleep disorders.

Participants will:

* Participate in an occupational therapy program for 6 weeks (including group therapy, individual treatment, and daily occupational tasks)

* Complete questionnaires at 1, 3, and 6 months after the program for follow-up

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-15
• Study First Posted: 2024-08-19
• Study Start: 2024-11-01
• Status Verified: 2025-08
• Last Update Submitted: 2025-09-03
• Last Update Posted: 2025-09-10
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• ≥18 years of age
• self-reported difficulties with sleep quality
• active sleep disturbance as indicated by a PSQI > 5 or an ISI ≥ 8 at screening
• able to participate in research independently or with the assistance of a caregiver
• participate voluntarily in the study and sign an informed consent form

Exclusion Criteria

• unable to cooperate with the study process due to cognitive, sensory, and motor dysfunction
• unable to skillfully use wearable monitoring devices or smartphones
• diagnosed with severe cardiac, liver, and kidney dysfunction and nervous system diseases
• have cardiac pacemakers
• being pregnant
• participating in other clinical trials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index	6 months	Using the PSQI to measure sleep quality
Insomnia Severity Index	6 months	Using the ISI to measure sleep quality
36-Item Short Form Survey (SF-36)	6 months	Using the SF-36 to measure quality of life

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing Municipality, China