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Active, Not Recruiting

NCT Number: NCT06558929

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Circadian Rhythm Sleep-Wake Disorder Chronobiology Disorders Dyssomnias Mental Disorders Nervous System Diseases Occupational Diseases Sleep Disorders, Circadian Rhythm Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

occupational therapy

Behavioral

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

conventional treatment

Other

Participants will receive conventional treatment and education on sleep hygiene.

Primary outcomes

  1. Insomnia Severity Index

    Time frame: 6 months

    Using the ISI to measure sleep quality

  2. Pittsburgh Sleep Quality Index

    Time frame: 6 months

    Using the PSQI to measure sleep quality

  3. 36-Item Short Form Survey (SF-36)

    Time frame: 6 months

    Using the SF-36 to measure quality of life

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2024
Registry last updated
Sep 10, 2025

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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