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Clinical Trials/ISRCTN74082423
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.

Registry
who.int
Start Date
January 10, 2023
End Date
May 31, 2026
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity College London

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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