ISRCTN74082423
Active, not recruiting
未知
The clinical impact of customised positive airway pressure (PAP) therapy interfaces versus usual care in the treatment of patients with sleep-disordered breathing
niversity College London0 sites160 target enrollmentJanuary 10, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity College London
- Enrollment
- 160
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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