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

NCT ID: NCT06558929

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2026-07-31

Brief Summary

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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

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Conditions

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Circadian Rhythm Sleep-Wake Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Occupational Therapy

Intervention Type BEHAVIORAL

Participants will redesign their daily routine with support from occupational therapists and an online health management platform.

Conventional Treatment

Intervention Type OTHER

Participants will receive conventional treatment and education on sleep hygiene.

Interventions

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Occupational Therapy

Participants will redesign their daily routine with support from occupational therapists and an online health management platform.

Intervention Type BEHAVIORAL

Conventional Treatment

Participants will receive conventional treatment and education on sleep hygiene.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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MOHar-CRSWD-001

Identifier Type: -

Identifier Source: org_study_id

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