Circadian Rhythm Sleep-Wake DisorderNCT06558929
Evaluating the Effectiveness of Intervention Based on the Model of Occupational Harmony in Patients With Sleep Disorders
A study testing Occupational Therapy and Conventional Treatment in people with Circadian Rhythm Sleep-Wake Disorder, run by Peking University First Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Circadian Rhythm Sleep-Wake Disorder
- What is being tested?
- Occupational Therapy and Conventional Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
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?
Read more
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
- Conditions
- Circadian Rhythm Sleep-Wake Disorder
- Being tested
- Occupational Therapy, Conventional Treatment
- Medical subject headings
- Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational TherapyBehavioural
Participants will redesign their daily routine with support from occupational therapists and an online health management platform.
Conventional TreatmentOther
Participants will receive conventional treatment and education on sleep hygiene.
| Study group | Role | What they receive |
|---|---|---|
| Occupational Intervention Group | Experimental | 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. Receives: Behavioral: Occupational Therapy; Other: Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
Using the ISI to measure sleep quality
Measured: 6 months
Pittsburgh Sleep Quality Index
Using the PSQI to measure sleep quality
Measured: 6 months
36-Item Short Form Survey (SF-36)
Using the SF-36 to measure quality of life
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Nov 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian Rhythm Sleep-Wake DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558929
- Sponsor's protocol ID
- MOHar-CRSWD-001
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2024
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Intervention Based on the Model of Occupational Harmony in Patients With Sleep Disorders
- ClinicalTrials.gov ID
- NCT06558929
- Acronym / sponsor ID
- MOHar-CRSWD-001
- Conditions
- Circadian Rhythm Sleep-Wake Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Occupational Intervention Group | Experimental | Behavioral: Occupational Therapy, Other: Conventional TreatmentThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational TherapyParticipants will redesign their daily routine with support from occupational therapists and an online health management platform. | Behavioural | Occupational Intervention Group |
| Conventional TreatmentParticipants will receive conventional treatment and education on sleep hygiene. | Other | Occupational Intervention Group |
Primary outcome
Insomnia Severity Index
Time frame: 6 months
Using the ISI to measure sleep quality
Pittsburgh Sleep Quality Index
Time frame: 6 months
Using the PSQI to measure sleep quality
36-Item Short Form Survey (SF-36)
Time frame: 6 months
Using the SF-36 to measure quality of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Therapy and Conventional Treatment in people with Circadian Rhythm Sleep-Wake Disorder, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.