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Effect of nocturnal oxygen treatment on obstructive sleep apnea/hypopnea syndrome in highlanders: Randomized, controlled, double-blinded trial

Effect of nocturnal oxygen treatment on obstructive sleep apnea/hypopnea syndrome in highlanders: Randomized, controlled, double-blinded trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017715
Enrollment
Unknown
Registered
2018-08-10
Start date
2018-08-13
Completion date
Unknown
Last updated
2018-08-20

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

Interventions

Oxygen:Oxygen
Sham oxygen:Sham oxygen (air)

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
30 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Men, aged 30 to 60 years; 2. Tibetan ethnicity, born and living at an elevation of 3200 m for over 10 years; 3. High risk of obstructive sleep apnea syndrome according to Berlin Questionnaire with a complaint of excessive sleepiness, witnessed snoring and apnea or other symptoms; 4. An oxygen desaturation index (typical >3% dips) of >30/h according to ambulatory nocturnal pulse oximetry 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 (fasting blood glucose >6.5 mmol/L) and previous stoke; 2. Exposed to low altitude (altitude below 1500 m) or higher altitude (altitude over 4000 m) in the previous half year for more than 1 week; 3. Chronic respiratory disease and/or chronic hypercapnia respiratory failure, such as chronic obstructive pulmonary disease (FEV1/FVC 6 kPa); 4. Liver dysfunction (ALT and AST over 2 fold of upper limit value), renal dysfunction (eGFR <50 ml/min/1.73m2) 5. Chronic mountain sickness (Qinghai CMS score over 6); 6. Other sleep disorders, such as insomnia, narcolepsy, restless leg syndromes, rapid eye movement behavior disorder and so on; 7. Internal, neurologic or psychiatric disease that may prevent compliance with the protocol.

Design outcomes

Primary

MeasureTime frame
AHI;

Secondary

MeasureTime frame
Mean nocturnal oxygen saturation;Oxygen desaturation index;Sleep structure;PVT response speed (1/ reaction time);Subjective well being, sleep quality, questionnaire evaluations;

Countries

China

Contacts

Public ContactTang Xiangdong

West China Hospital, Sichuan University

2372564613@qq.com+86 18980602059

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 23, 2026