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Obstructive sleep apnea hypopnea syndrome with a time-restricted eating diet and a calorie restrict diet: a randomised controlled trial

Obstructive sleep apnea hypopnea syndrome with a time-restricted eating diet and a calorie restrict diet: a randomised controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069294
Enrollment
Unknown
Registered
2023-03-13
Start date
2023-03-13
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Obstructive sleep apnea hypopnea syndrome (OSA)

Interventions

time-restricted eating diet group:With 8h fasting, the eating time is 7:00~15:00, and the rest of the day is fasted. Ensure that you complete at least 6 days a week and record the start and end of eat
calorie restrict diet group:Reduce the target energy intake by 300 kcal/d according to the subjects. The eating time limit within 1 day must be greater than 8 hours.

Sponsors

Eye&ENT Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. High school degree or above; 2. OSA adult males aged 18-65 years (AHI >= 5 times/hour); 3. BMI>=28.0kg/m^2; 4. No history of surgical treatment for OSAS; 5. No vision or cognitive impairment (normal vision or corrected to normal vision).

Exclusion criteria

Exclusion criteria: 1. Dementia, cerebrovascular disease, history of brain trauma, chronic respiratory disease; 2. Other primary sleep disorders; 3. Combined mental disorders (including depression, anxiety, alcoholism and other drug addictions); 4. Other serious systemic and organ diseases with non-OSA comorbidities such as tumors; 5. OSA patients who had undergone surgery and drug therapy; 6. Routine use of psychiatric system, anti-anxiety and depression drugs or drugs that can cause sleep structure disorders; 7. Non-OSA induced daytime sleepiness; 8. Associated with congenital or acquired craniofacial malformations such as Crouzon, Apert, Treacher-Collins, Robin sequence, Down syndrome, etc.; 9. Performed craniofacial surgery (including orthodontic surgery, plastic surgery, orthodontic).

Design outcomes

Primary

MeasureTime frame
feeding window;visceral fat area, VFA;weight;hip circumference;waist circumference;food frequency questionnaire;blood glucose;weight self-stigma questionnaire;blood lipid;body composition;

Countries

China

Contacts

Public ContactHuang Jingjing

Eye&ENT Hospital of Fudan University

gennie_xuan@163.com+86 137 0174 0606

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026