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Effect of acetazolamide on obstructive sleep apnea in highlanders: A randomized, placebo-controlled, double-blinded crossover trial

Effect of acetazolamide on obstructive sleep apnea in highlanders: A randomized, placebo-controlled, double-blinded crossover trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049304
Enrollment
Unknown
Registered
2021-07-29
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-11-06

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

Conditions

obstructive sleep apnea in highlanders

Interventions

Acetazolamide group (Tibetan):Acetazolamide
Placebo group (Tibetan):Placebo
Acetazolamide group (Han):Acetazolamide
Placebo group (Han):Placebo

Sponsors

Sleep Medicine Center, West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Both sexes, aged 30-60 years, Tibetan and Han ethnicity 2. Tibetans should be living at an elevation of 3650 m for over 10 years or born and living at an elevation of 3650 m; Hans should be living at an elevation of 3650 m for over 5 years or born and living at an elevation of 3650 m 3. An AHI of over 15 /h according to baseline PSG during a screening evaluation

Exclusion criteria

Exclusion criteria: 1. Unstable cardiovascular disease, such as angina, coronary heart disease, hypertension (systolic pressure >160 mmHg, diastolic pressure >100 mmHg) and atrial fibrillation, uncontrolled diabetes and previous stroke 2. Taking antihypertensive medication, receiving continuous positive airway pressure therapy or mandible advancement therapy currently 3. History of surgery such as uvulopalatopharyngoplasty (UPPP) to relieve OSA 4. Exposed to lower altitude (altitude 5000 m) in the previous half year for more than 1 week 5. History of chronic respiratory disease and/or chronic hypercapnia respiratory failure, such as chronic obstructive pulmonary disease (FEV1/FVC6kPa) 6. Liver dysfunction (ALT and AST over 2-fold of upper limit value), renal dysfunction (eGFR<50 ml/min/1.73m2), previous history of renal calculi 7. Chronic mountain sickness (Qinghai CMS score over 6) 8. History of allergy to sulfanilamide or sulfanilamide derivatives or taking concomitant medication that may interfere with acetazolamide (i.e. high dose of acetylsalicylic acid) 9. Other sleep disorders, such as insomnia, narcolepsy, restless leg syndrome, rapid eye movement behavior disorder and so on 10. Pregnancy or lactation 11. Internal, neurologic or psychiatric disease that may prevent compliance with the protocol

Design outcomes

Primary

MeasureTime frame
24-hour mean blood pressure;

Secondary

MeasureTime frame
Apnea-hypopnea index;Mean nocturnal oxygen saturation;Oxygen desaturation index;24-hour systolic and diastolic blood pressure;Daytime mean blood pressure;Daytime systolic and diastolic blood pressure;Nighttime systolic and diastolic blood pressure;Sleep quality and sleep structure;PVT response speed;Cerebral tissue oxygenation and desaturation;ECG changes and QTc duration;Nocturnal hypoxic burden;Overnight fluid shift;

Countries

China

Contacts

Public ContactTang Xiangdong

Sleep Medicine Center, West China Hospital, Sichuan University

2372564613@qq.com+86 189 8060 2059

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026