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Clinical Trials/NCT06558929
NCT06558929
Active, Not Recruiting
N/A

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

Peking University First Hospital1 site in 1 country40 target enrollmentNovember 1, 2024
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ConditionsCircadian Rhythm Sleep-Wake Disorder

Overview

Phase
N/A
Intervention
Not specified
Conditions
Circadian Rhythm Sleep-Wake Disorder
Sponsor
Peking University First Hospital
Enrollment
40
Locations
1
Primary Endpoint
Pittsburgh Sleep Quality Index
Status
Active, Not Recruiting
Last Updated
7 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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
Registry
clinicaltrials.gov
Start Date
November 1, 2024
End Date
July 31, 2026
Last Updated
7 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pittsburgh Sleep Quality Index

Time Frame: 6 months

Using the PSQI to measure sleep quality

Insomnia Severity Index

Time Frame: 6 months

Using the ISI to measure sleep quality

36-Item Short Form Survey (SF-36)

Time Frame: 6 months

Using the SF-36 to measure quality of life

Study Sites (1)

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