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A randomized, controlled crossover trial of acute intermittent and continuous hypoxia exposure for mild-moderate obstructive sleep apnea

A randomized, controlled crossover trial of acute intermittent and continuous hypoxia exposure for mild-moderate obstructive sleep apnea

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065874
Enrollment
Unknown
Registered
2022-11-17
Start date
2022-11-22
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

obstructive sleep apnea

Interventions

Normoxia:Patients undergoing normoxic exposure continuously inhaled air (O2 21%) through a mask for 50 minutes.
Acute continuous hypoxia, ACH:A 25-minute hypoxia exposure (O2 10~12%) is continuously administered before sleep, followed by inhalation of air (O2 21%) for 25 minutes, with the total exposure time of
Acute intermittent hypoxia, AIH:5×5 min hypoxia exposure (O2 10~12%) are administered. The subjects are alternately exposed to hypoxia for 5 min and 5-min air (O2 21%), for 5 consecutive cycles, with

Sponsors

Renmin Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 18-50 years with a diagnosis of OSA; 2. AHI < 30 events per hour and BMI < 30 kg/m2; 3. Without acute or chronic cardiopulmonary diseases; 4. No prior history of pharyngeal surgery aside from tonsillectomy and no palatine tonsillar hypertrophy (grade III or IV); 5. Signed informed consent before any study procedure.

Exclusion criteria

Exclusion criteria: 1. No predominant OSA evidenced at baseline; 2. Regular use of sedative drugs such as benzodiazepines, opiates, and antipsychotics; 3. Acute nasal congestion during upper airway infection; 4. Known severe respiratory tract allergies, e.g. severe allergic asthma; 5. Any other condition making the subject unsuitable for this study and disallowing participation for the full planned study period, e.g. known history of severe heart failure or severe chronic obstructive pulmonary disease, confirmation of pregnancy; 6. Inability to comply with the planned study procedures or with the study protocol requirements.

Design outcomes

Primary

MeasureTime frame
Apnea hyponea index, AHI;Oxygen desaturation index, ODI;

Secondary

MeasureTime frame
Adverse events;

Countries

China

Contacts

Public ContactHu Ke

Renmin Hospital of Wuhan University

huke-rmhospital@163.com+86 18971035988

Outcome results

None listed

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