Comparison of adherence of different nasal masks in Obstructive Sleep Apnea patients treated by CPAP therapy

Completed

• Conditions: Respiratory; ewly-diagnosed obstructive sleep apnea (OSA) patients treated by CPAP; Obstructive sleep apnea (OSA)

• Registration Number: ISRCTN39453867
• Lead Sponsor: ResMed

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-27
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 228

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified