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

September 3, 2025 updated by: Peking University First Hospital

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Occupational Intervention Group
The intervention group will participate in a 6-week occupational therapy program, which includes 3 group treatment sessions, 1 individual treatment session, and daily occupational tasks.
Other: Conventional Treatment
Participants will receive conventional treatment and education on sleep hygiene.
Behavioral: Occupational Therapy
Participants will redesign their daily routine with support from occupational therapists and an online health management platform.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

August 13, 2024

First Submitted That Met QC Criteria

August 15, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 10, 2025

Last Update Submitted That Met QC Criteria

September 3, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOHar-CRSWD-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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