Multi-centre randomised controlled trial to investigate the efficacy of nasal continuous positive airway pressure treatment to reduce cardiovascular risk and symptoms in mild to moderate sleep apnoea
| ISRCTN | ISRCTN34164388 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34164388 |
| Secondary identifying numbers | MOSAIC 1 |
- Submission date
- 16/09/2005
- Registration date
- 05/10/2005
- Last edited
- 18/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=19
Contact information
Prof John Stradling
Scientific
Scientific
Oxford Sleep Unit
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom
Study information
| Study design | Multi-centre randomised controlled |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Multi-centre randomised controlled trial to investigate the efficacy of nasal continuous positive airway pressure treatment to reduce cardiovascular risk and symptoms in mild to moderate sleep apnoea |
| Study acronym | Multi-centre Obstructive Sleep Apnoea Interventional Cardiovascular Trial (MOSAIC) |
| Study objectives | Patients with Obstructive Sleep Apnoea (OSA) are treated with nasal continuous positive airway pressure (CPAP) to control excessive daytime sleepiness, and to reduce vascular risk by improving blood pressure (BP), and possibly other vascular risk factors. Randomised trials for one month have shown falls in BP following treatment for disease at the more severe end of the spectrum, but not for less severe disease where treatment benefits are currently unproven. If the treatment of less severe disease produces similar benefits, this will be a substantial therapeutic advance in vascular risk reduction, since this disease affects up to 6% of men. If ineffective, the substantial treatment costs would be better directed elsewhere. The randomised trial proposed here will determine whether treating less severe sleep apnoea reduces calculated vascular risk, surrogate measures of cardiovascular disease, symptomatic benefits, and will determine the feasibility of a subsequent phase 3, long-term, trial to quantify any actual reduction in vascular event rate. |
| Ethics approval(s) | Oxfordshire REC A, 15/12/2005, ref: 05/Q1604/159 |
| Health condition(s) or problem(s) studied | Sleep apnoea |
| Intervention | Nasal CPAP machines versus no intervention |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 1. Reduction in the cardiovascular risk using the Framingham score 2. Reduction in Epworth Sleepiness Score |
| Secondary outcome measures | 1. Fall in insulin resistance 2. Fall in HbA1c 3. Platelet activation 4. BP variability 5. Fasting triglycerides 6. Obesity and its distribution 7. Carotid wall volume 8. Brain magnetic resonance imaging (MRI) indices of hypertensive damage 9. Diastolic function 10. Pulse wave analysis 11. Reduction in adverse cardiovascular events 12. Improvement in self assessed health status and ability to resist sleep 13. Reduction health services utilisation |
| Overall study start date | 02/01/2006 |
| Completion date | 02/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 400 |
| Key inclusion criteria | 1. Objectively confirmed obstructive sleep apnoea on respiratory polysomnography, with a >4% arterial oxygen desaturation index of >7.5/hour 2. Written informed consent |
| Key exclusion criteria | 1. Sleep apnoea symptoms of sufficient severity that CPAP is mandated by current trial evidence, such that randomisation to a control would be unethical (this decision is in the hands of the randomising physician as the equipoise point varies between units, but guidance on this is presented later) 2. Ventilatory failure (awake resting arterial oxygen saturation <93% or arterial pCO2 >6kPa) 3. Clinic BP more than 180/110 4. Cheyne-Stokes breathing on respiratory polysomnography 5. Current Heavy Goods Vehicle or Public Service Vehicle driving licence holder 6. Any sleep related accident 7. Age <45 or >75 years at trial entry (age range selected as it is typical for patients with OSA and will have a significant cardiovascular event rate) 8. Previous exposure to CPAP or non-invasive ventilation 9. Mental or physical disability precluding informed consent or compliance with the protocol for the duration of the study 10. Non-feasible trial follow-up (for example, distance from follow-up centre, physical inability) 11. Any co-incidental illness making survival for two years unlikely |
| Date of first enrolment | 02/01/2006 |
| Date of final enrolment | 02/01/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Churchill Hospital
Oxford
OX3 7LJ
United Kingdom
OX3 7LJ
United Kingdom
Sponsor information
Oxford Radcliffe Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development Department
Manor House
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DZ
England
United Kingdom
"ROR" |
https://ror.org/03h2bh287 |
|---|
Funders
Funder type
Charity
British Heart Foundation (UK) - PG/05/068
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2012 | Yes | No | |
| Results article | results | 01/09/2013 | Yes | No | |
| Results article | substudy results | 01/09/2013 | Yes | No | |
| Results article | results | 01/10/2014 | Yes | No | |
| Results article | results | 01/02/2015 | Yes | No | |
| Results article | results | 15/09/2015 | Yes | No | |
| Results article | results | 16/03/2016 | Yes | No |
Editorial Notes
18/03/2016: Publication reference added.
