Obstructive sleep apnea
Conditions
Interventions
Intervention group:The intervention group received the best supportive treatment of oral riboflavin plus OSA, in which riboflavin was distributed by the research group (Shanghai New Yellow River Pharm
Control group:The control group received oral placebo plus the best supporting treatment of OSA. The placebo was given by the research group, and the oral regimen was the same as that of the intervent
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: ?The first diagnosis of mild to moderate OSA was made between October 2022 and September 2026 according to the Multidisciplinary Guidelines for the Management and Treatment of Obstructive Sleep Apnea in Adults. ? Age 30-65 years old, body mass index (BMI) <30kg/m2, gender is not limited; ? Epworth daytime sleepiness score <11; ? no history of hypertension; ? Normal renal function (serum urea 2.5-6.4mmol/L; Serum creatinine 53-115µmol/L; Uric acid 210-430µmol/L); ? Volunteer to participate in this clinical study, sign informed consent, and cooperate with the completion of randomization and follow-up.
Exclusion criteria
Exclusion criteria: ?Previous diagnosis of other sleep disorders (narcolepsy, insomnia, chronic sleep deprivation, REM behavior disorder and restless leg syndrome, central sleep apnea or obesity hypopnea syndrome); ?Have previously received, or plan to receive, internal and surgical treatment for OSA in addition to the best supportive treatment during the study period (non-invasive positive pressure ventilation, oral orthodontics, posture therapy, oxygen therapy, drugs, and surgery); ? Tonsil position of 3 degrees or more, or accompanied by severe craniomaxillofacial deformity; ? Serious underlying diseases, including circulatory system diseases (heart failure, arrhythmia and stroke, etc.), respiratory system diseases (respiratory failure, pulmonary embolism, etc.), liver decompensation, malignant tumors, etc.; Suffering from depression, mania, schizophrenia and other mental disorders; Suffering from tuberculosis, AIDS, syphilis and other infectious diseases; ? The average daily smoking amount is more than 5 cigarettes or habitual use of nicotine-containing products in the 3 months before screening; Or consume an average of more than 14 units of alcohol per week (1 unit of alcohol =360 mL beer, or 45 mL spirits with 40% alcohol or 150 mL wine); ? The woman is pregnant, breastfeeding, or has a pregnancy plan during the study period; The man's wife or partner planned to become pregnant during the study period; ? Allergic constitution or allergy to riboflavin; ? Currently using, or planning to take a multivitamin within 6 months after screening; ? Participants who have participated in any drug or medical device clinical trial within 3 months before screening; ? Researchers believe that there are any reasons not suitable to participate in the study, such as the existence of uncorrectable visual and hearing disorders can not complete the scale assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apnea hyponea index; | — |
Secondary
| Measure | Time frame |
|---|---|
| ESS score;Quebec Sleep Questionnaire score;Pittsburgh Sleep Quality Index;Baker depression scale;Montreal Cognitive Assessment Questionnaire; | — |
Countries
China
Contacts
Public ContactLiu Yupu
Shanghai Sixth People's Hospital
Outcome results
None listed