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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06558929
Enrollment
40
Registered
2024-08-19
Start date
2024-11-01
Completion date
2026-07-31
Last updated
2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circadian Rhythm Sleep-Wake Disorder

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

Interventions

BEHAVIORALOccupational Therapy

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

OTHERConventional Treatment

Participants will receive conventional treatment and education on sleep hygiene.

Sponsors

Peking University First Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Insomnia Severity Index6 monthsUsing the ISI to measure sleep quality
Pittsburgh Sleep Quality Index6 monthsUsing the PSQI to measure sleep quality
36-Item Short Form Survey (SF-36)6 monthsUsing the SF-36 to measure quality of life

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026