An Investigation to Test the Efficacy of the High Flow (HF) Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea (OSA)
Obstructive Sleep Apnea
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Aged ≥ 18 years.
- AHI > 15 events per hour and ≥ 90% of events must be Hypopneas.
Exclusion Criteria:
- Any medical condition which contraindicates the use of CPAP or AutoCPAP. See Appendix D for this list.
- Requires supplemental oxygen.
- Unstable cardiovascular disease (untreated or resistant hypertension acceptable).
- Unstable psychiatric disease.
- Other significant sleep disorder.
- Inability to tolerate CPAP due to nasal obstruction or claustrophobia, as determined by the investigation investigator.
- Any known factor or disease that might interfere with treatment compliance, investigation conduct or interpretation of the results such as psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with investigational requirements.
- Participation in another clinical investigation in the previous month.
Sites / Locations
- HELIOS-Klinik Hagen Ambrock
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
CPAP
HFCPAP
Continuous Positive Airway Pressure (CPAP) is the gold-standard treatment for OSA. CPAP mechanically splints the upper airway open during sleep to prevent collapse and in this way ameliorates OSA. Dose: The CPAP pressure will be set to the individual subject's therapeutic pressure -as determined by PSG on Night 2. Duration: 1 night - the duration of the subject's sleep period (minimum of 3 hrs of sleep required)
Continuous Positive Airway Pressure (CPAP) is the gold-standard treatment for OSA. CPAP mechanically splints the upper airway open during sleep to prevent collapse and in this way ameliorates OSA. Dose: During HF CPAP 35 L/min wil be administered. Duration: 1 night - the duration of the subject's sleep period (minimum of 3 hrs of sleep required)