The impact of changing the pressure generating device in people with sleep apnoea using Continuous Positive Airway Pressure (CPAP) less than 4 hours per night

Not Applicable

Completed

• Conditions: Obstructive sleep apnoea; Respiratory; Sleep disorders

• Registration Number: ISRCTN31885415
• Lead Sponsor: Papworth Hospital NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-18
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Diagnosed OSA (AHI greater than 4 per hour)
2. On CPAP for at least 6 weeks with average use less than 4 hours per night
3. Intolerant of CPAP despite ensuring pressure minimised to least effective, mask fit and humidification reviewed as appropriate

Exclusion Criteria

1. Refuse informed consent or unable to give consent.
2. AHI less than 5 per hour off CPAP.
3. Moderate to severe airflow obstruction (Forced Expiratory Volume in 1 second [FEV1] / Forced Vital Capacity Percentage [FVC%] less than 60%).
4. Central sleep apnoea (central events more than 50% of all the apnoeas / hypopnoeas).
5. Decompensated congestive heart failure on clinical examination.
6. Hypercapnia (PaCO2 >6.5 KPa).
7. Previous exposure to Bi-level positive airway pressure support.

Study & Design

• Study Type: Interventional
• Study Design: Not specified