Investigating customised positive airway pressure therapy masks versus usual care in the treatment of patients with sleep-disordered breathing

The clinical impact of customised positive airway pressure (PAP) therapy interfaces versus usual care in the treatment of patients with sleep-disordered breathing

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN74082423

Enrollment

160

Registered

2023-01-10

Start date

2023-01-16

Completion date

Unknown

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory disorders Respiratory

Interventions

The following examinations and investigations (if not already performed as part of routine standard of care) shall be performed for determining eligibility for enrolment into this Investigation: RCT

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion 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 >= 18 years Nested Qualitative Study: Patients participating in study 1

Exclusion criteria

Exclusion criteria: Randomised controlled trial: 1. AHI <15 2. Excessive facial hair which they are unwilling to shave 3. Age <18 years 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

Design outcomes

Primary

Measure	Time frame
Apnoea hypopnea index (AHI) measured using the limited cardio-respiratory sleep study at 6 months	—

Secondary

Measure	Time frame
1. Apnoea hypopnea index (AHI) measured using the limited cardio-respiratory sleep study at 3 months 2. Interface leak measured using average L/min and percentage of the intentional leak over 7 days from positive airway pressure (PAP) therapy data downloads at 3 and 6 months 3. Residual AHI measured using PAP therapy data downloads for further validation of AHI at 3 and 6 months 4. Incidence of pressure ulcers measured using the European Pressure Ulcer Advisory Panel (EPUAP) score (0 to 4) at 3 and 6 months 5. Compliance with PAP therapy, measured as hours and percentage of days PAP therapy used >4 hours/night over 28 days, measured prior to 3 and 6 months 7. Symptoms measured using the Epworth Sleepiness Score (ESS) and Sleepiness-Wakefulness Inability and Fatigue test (SWIFT) at baseline, and 3 and 6 months. 8. Comfort as measured by the S3-non-invasive ventilation (S3NIV) questionnaire and the interface questionnaire, at baseline, and 3 and 6 months.	—

Measure

Time frame

1. Apnoea hypopnea index (AHI) measured using the limited cardio-respiratory sleep study at 3 months 2. Interface leak measured using average L/min and percentage of the intentional leak over 7 days from positive airway pressure (PAP) therapy data downloads at 3 and 6 months 3. Residual AHI measured using PAP therapy data downloads for further validation of AHI at 3 and 6 months 4. Incidence of pressure ulcers measured using the European Pressure Ulcer Advisory Panel (EPUAP) score (0 to 4) at 3 and 6 months 5. Compliance with PAP therapy, measured as hours and percentage of days PAP therapy used >4 hours/night over 28 days, measured prior to 3 and 6 months 7. Symptoms measured using the Epworth Sleepiness Score (ESS) and Sleepiness-Wakefulness Inability and Fatigue test (SWIFT) at baseline, and 3 and 6 months. 8. Comfort as measured by the S3-non-invasive ventilation (S3NIV) questionnaire and the interface questionnaire, at baseline, and 3 and 6 months.

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026