ISRCTN39453867
Completed
Not Applicable
Impact of different nasal masks on CPAP therapy for obstructive sleep apnea: a randomized comparative trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ResMed
- Enrollment
- 228
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Newly\-diagnosed Obstructive Sleep Apnoea / Hypopnoea Syndrome (OSAHS) patients
- •2\. Daytime sleepiness and \=3 of listed symptoms (snoring, morning headaches, reduced alertness, libido disorders, hypertension or nocturia) associated with an apnea\-hypopnea index (AHI) of \>30/h or 5\-30/h with \=10 respiratory event\-related arousals with an increase in respiratory effort documented by polysomnography (PSG),
- •3\. Central apnea index of \=20%,
- •4\. Absence of nocturnal mouth leaks detected during CPAP treatment initiation,
- •5\. No known allergy to silicone,
- •6\. Fitted with an automatic positive airway pressure (APAP) device (S9 AutoSet; ResMed)
Exclusion Criteria
- •1\. Refusal or unable to participate
- •2\. First\-line nasal mask other than those being assessed
- •3\. Patient previously treated with CPAP/APAP or noninvasive positive pressure ventilation
- •4\. Has undergone Ear, nose and throat (ENT) surgery within the previous 6 weeks
- •5\. Significant epistaxis in the previous 6 months,
- •6\. Patient participating in another clinical trial
Outcomes
Primary Outcomes
Not specified
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