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Therapeutic effects of sleep restriction therapy on obesity

Therapeutic effects of sleep restriction therapy on obesity

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078587
Enrollment
Unknown
Registered
2023-12-13
Start date
2024-01-05
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

Obesity

Interventions

Control Group:None
Treatment Group:Sleep restriction therapy

Sponsors

The First People's Hospital of Xiangtan City
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Understand the procedures and methods of the study, participate in the trial voluntarily, be able to cooperate with the trial, and sign the informed consent in writing; 2. Male, aged 20-40 years, with BMI between 28-35kg/m^2, and diagnosed as obesity by a specialist; no other weight loss treatment has been received in the last 2 months; 3. Screen positive for insomnia symptoms on the Sleep Status Index and meet DSM-5 criteria for insomnia disorders; 4. Self-reported sleep efficiency of less than 85% in the past month; 5. Ability to attend appointments and comply with study procedures during the trial period.

Exclusion criteria

Exclusion criteria: 1. A history of strenuous exercise, tobacco or caffeine use, a history of alcohol consumption [more than 15g of alcohol per day (equivalent to 350mL of beer, 150mL of wine, or 45mL of distilled spirits) more than twice per week], or a history of substance abuse; 2. A history of a medical condition that may interfere with the interpretation of the results that could lead to secondary obesity, such as cortisolism, hypothyroidism, hypothalamic or pituitary disorders, pancreatic related disorders such as pancreatic beta-cell tumors, and so on; 3. Diseases for which sleep restriction therapy may be contraindicated or render inappropriate or ineffective: additional diagnoses of sleep disorders (e.g.restless legs syndrome, obstructive sleep apnea, or episodic somnambulism) or dementia or mild cognitive impairment; epilepsy, schizophrenia, or bipolar disorder; 4. Current suicidal ideation or attempted suicide within the past 2 months; 5. Currently undergoing cancer treatment or planning to undergo major surgery during the treatment phase; 6. Working nights, evenings, early mornings or shifts; 7. Currently receiving psychotherapy for insomnia from a health professional or participating in an online insomnia treatment program; 8. Ineligible for enrollment due to the presence of a major medical condition: previous history of myocardial infarction, coronary heart disease, angina pectoris, heart failure (class II-IV), severe arrhythmia (e.g., atrial fibrillation, need for a pacemaker); 9. History of hepatitis B, hepatitis C, AIDS, syphilis and other infectious diseases; 10. Patients with moderate to severe anemia (hemoglobin less than 90g/L); 11. Those who have participated in blood donation or lost 400mL or more of blood within 3 months prior to the screening, or those who have received blood transfusion within 3 months prior to the screening; 12. Those who have had serious trauma or major surgery within 1 month prior to screening, or those who plan to undergo surgery during the trial; 13. Any condition that, in the opinion of the investigator, may cause the subject to be unable to complete the study or pose a significant risk to the subject, or any other factor that reduces the likelihood of enrollment.

Design outcomes

Primary

MeasureTime frame
Phsical Examination;Body Composition Analysis;Sleep Analysis;

Secondary

MeasureTime frame
VAS scoring scale;Total energy intake per day;

Countries

China

Contacts

Public ContactGenqing Xie

The First People's Hospital of Xiangtan City

genqingxie@qq.com+86 181 6360 2595

Outcome results

None listed

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