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

ISRCTN ISRCTN31885415
DOI https://doi.org/10.1186/ISRCTN31885415
Secondary identifying numbers N/A
Submission date
07/01/2010
Registration date
18/03/2010
Last edited
05/07/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ian Smith
Scientific

Respiratory support and sleep centre
Papworth Hospital NHS Trust
Papworth Everard
Papworth Everard
CB23 3RE
United Kingdom

Study information

Study designSingle-centre two-period two-arm randomised controlled crossover group trial
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleThe 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
Study objectivesDoes changing to Bi−level positive airway pressure (Bi−level PAP) support increases usage in obstructive sleep apnoea (OSA) patients who have suboptimal compliance with fixed continuous positive airway pressure (CPAP) due to pressure intolerance?

The most effective treatment for symptomatic, moderate to severe OSA is with CPAP. To derive optimal benefit it is recommended that CPAP should be used for at least 4 hours per night. However, only 46-83 % of individuals use it for more than 4 hours every night. Different mechanical interventions (Auto positive airway pressure, Bi-level Positive airway pressure, and expiratory release positive airway pressure) have failed to show any significant improvement in compliance. Most of these studies have studied unselected subjects first initiating therapy. It is possible that subjects who after all simple measures to improve compliance have been addressed are still non-compliant may show a demonstrable improvement with a change of mode of pressure delivery. In this study we will evaluate the role of Bi-level PAP in OSA patients who remain poorly compliant with CPAP (despite appropriate interventions to improve local side effects and/or who complain of pressure related problems).
Ethics approval(s)Cambridgeshire 2 Research and Ethics Committee (REC), April 2009, ref: 09/H0308/68
Health condition(s) or problem(s) studiedObstructive sleep apnoea
InterventionThe 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 exclusion criteria will be randomised to either receive a Bi-level positive airway pressure (Bi-PAP) device first or to receive a brand of fixed CPAP machine different from the one they have used previous to entering the study. They will have a baseline measure of CPAP compliance, daytime sleepiness and quality of life. Both groups will receive a similar level of continuing clinical support by the CPAP practitioners and Respiratory Support and Sleep Centre (RSSC) nurses (24 hour telephone helpline, early clinic review and advice if there is any problem) as per the standard clinical care at our centre.
They will then be reviewed at 4 weeks with repeat measurements of compliance, sleepiness and quality of life.
For the second period, those that received CPAP in the first period will get Bi-level PAP and vice versa. They will go home with the advice to start using the new device after 2 weeks. Until that time they will stay on their initial CPAP. This will give them a washout period of two weeks. They will then be followed up for the study at 10 weeks with repeat measures of CPAP compliance, daytime sleepiness and quality of life indices to look for any measurable changes.
Patients will be selected from a cohort of CPAP users who are followed up at Papworth hospital.
Intervention typeDevice
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measureCPAP compliance (measured as average CPAP use in hours per night)
Secondary outcome measures1. 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)
Overall study start date01/04/2009
Completion date30/04/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40
Key inclusion criteria1. 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
Key exclusion criteria1. 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.
Date of first enrolment01/04/2009
Date of final enrolment30/04/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Papworth Hospital NHS Trust
Papworth Everard
CB23 3RE
United Kingdom

Sponsor information

Papworth Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

Dr Alistair Grant
Senior R and D manager
Papworth hospital NHS foundation trust
Papworth Everard
CB23 3RE
England
United Kingdom

ROR logo "ROR" https://ror.org/01qbebb31

Funders

Funder type

Hospital/treatment centre

Papworth Hospital NHS Foundation Trust (UK) - (Local R& D ref: PO1349)

No information available

B and D electromedicals (UK) - limited funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2015 Yes No

Editorial Notes

05/07/2016: Publication reference added.