Investigating customised positive airway pressure therapy masks versus usual care in the treatment of patients with sleep-disordered breathing
Not Applicable
- Conditions
- Respiratory disordersRespiratory
- Registration Number
- ISRCTN74082423
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Randomised controlled trial:
1. Diagnosis of SDB (AHI > = 15) confirmed with a home-based sleep study and requiring PAP therapy
2. Patients naive to domiciliary PAP therapy
3. Age > = 18years
Nested Qualitative study:
Patients participating in study 1
Exclusion Criteria
Randomised controlled trial:
1. AHI < 15
2. Excessive facial hair which they are unwilling to shave
3. Age < 18years
4. Existing facial pressure ulcers
5. Unable to provide informed consent
6. Known allergy to silicone
7. Keloid scarring
8. Previous domiciliary PAP therapy
Nested Qualitative study
Patients who are unable to provide informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method