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

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: a randomised controlled crossover trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN31885415

Enrollment

Registered

2010-03-18

Start date

2009-04-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Obstructive sleep apnoea Respiratory Sleep disorders

Interventions

The study will have a two-period, two-treatment crossover randomised controlled trial design. Patients with average CPAP use less than 4 hours per night who meet the inclusion and none of the exclusio

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Secondary

Measure	Time frame
1. Improvement in generic quality of life index - Short form 36 (SF-36) 2. Improvement in sleep apnoea quality of life index (SAQLI) 3. Epworth sleepiness scale score (ESS) 4. Side effects 5. Comfort level 6. Patient preference for different device 7. Changes in objective measure of excessive daytime sleepiness (OSLER test)	—

Primary

Measure	Time frame
CPAP compliance (measured as average CPAP use in hours per night)	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026