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Clinical Study on the Effectiveness of Vitamin B2 Treatment for Obstructive Sleep Apnea Syndrome

Clinical Study on the Effectiveness of Vitamin B2 Treatment for Obstructive Sleep Apnea Syndrome

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050810
Enrollment
Unknown
Registered
2021-09-04
Start date
2021-10-01
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Obstructive sleep apnea syndrome

Interventions

Best supportive treatment group:Carry out the best supportive treatment
Best supportive treatment group and Vitamin B2(10 mg) group:Carry out the best supportive treatment and take vitamin B2(10 mg) three times a day
Best supportive treatment group and Vitamin B2(20 mg) group:Carry out the best supportive treatment and take vitamin B2(20 mg) three times a day

Sponsors

The Sixth People's Hospital Affiliated to Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. People with normal renal function aged 20-70 years: serum urea 2.5-6.4 mmol/L; blood creatinine 53-115 umol/L; uric acid 210-430 umol/L; 2. Sleep snoring more than 5 days a week, and apnea repeatedly occur or open mouth to breathe during sleep; 3. OSA patients with Friedman tonsils 0-1 degree diagnosed by laboratory standard polysomnography; 4. Participate in this clinical study voluntarily, sign an informed consent form, and be able to cooperate and complete the follow-up.

Exclusion criteria

Exclusion criteria: 1. Pregnant women or women who are breastfeeding; 2. Those who are allergic to vitamin B2; 3. Currently undergoing other treatments related to OSA; 4. Cardio-cerebrovascular diseases (heart failure, recurrent atrial fibrillation and stroke); respiratory diseases (respiratory failure, COPD); neurological diseases (epilepsy); advanced cancer and chronic inflammatory diseases; 5. Depression, mania, schizophrenia and other mental illnesses; 6. Those who are currently drinking regularly; 7. Currently using phenothiazines, tricyclic antidepressants, probenecid, metoclopramide (metoclopramide) and other drugs; or are using psychotropic drugs, sedatives, narcotics and other drugs; or using those with health products such as multivitamins that may have an impact on the research results; 8. Other sleep diseases: narcolepsy, insomnia, chronic sleep deprivation, REM behavior disorder and restless legs syndrome, central OSA or obesity hypopnea syndrome; 9. Have specified diseases or conditions excluded from research (physical or psychological, physical examination findings); 10. Participated in other clinical studies within 3 months before the start of the study or the investigator believes that there is any reason for not being suitable for participating in the trial.

Design outcomes

Primary

MeasureTime frame
Effective treatment (AHI index);

Secondary

MeasureTime frame
Compliance;Epworth Sleepiness Score and Quality of life score;

Countries

China

Contacts

Public ContactYin Shankai

The Sixth People's Hospital Affiliated to Shanghai Jiaotong University

skyin@sjtu.edu.cn+86 18930177096

Outcome results

None listed

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