ISRCTN93709209
Completed
Not Applicable
Therapy-efficacy of automatic positive airways pressure therapy with A-Flex compared to standard automatic positive airways pressure therapy in obstructive sleep apnoea (OSA) patients
Respironics International Inc. (France)0 sites40 target enrollmentMay 15, 2008
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obstructive sleep apnoea
- Sponsor
- Respironics International Inc. (France)
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Apnoea\-Hypopnoea Index (AHI) greater than 15/h confirmed by full polysomnograph (PSG)
- •2\. Aged greater than or equal to 21 to less than or equal to 65 years, either sex
- •3\. Body mass index (BMI) less than 40 kg/m^2
- •4\. Able to follow the study protocol
Exclusion Criteria
- •1\. Acute upper respiratory infection, encephalitis, sinusitis or middle ear infection
- •2\. Drug abuse
- •3\. Intake of central relevant drugs, sedatives, or other drugs which impair sleep
- •4\. Alcohol abuse
- •5\. Psychiatric or neurological diseases resulting in impairment of sleep, therapy or compliance
- •6\. Thyroidal dysfunction
- •7\. Chronic pain syndromes
- •8\. Acute cardiac, pulmonary, and other internal diseases
- •9\. Chronic cardiac, pulmonary and other internal diseases resulting in impairment of sleep
- •10\. Central sleep related breathing disorders or other disorders resulting in hypoventilation
Outcomes
Primary Outcomes
Not specified
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