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

Oxford Sleep Unit
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom

Study information

Study designMulti-centre randomised controlled
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleMulti-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 acronymMulti-centre Obstructive Sleep Apnoea Interventional Cardiovascular Trial (MOSAIC)
Study objectivesPatients 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) studiedSleep apnoea
InterventionNasal CPAP machines versus no intervention
Intervention typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure1. Reduction in the cardiovascular risk using the Framingham score
2. Reduction in Epworth Sleepiness Score
Secondary outcome measures1. 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 date02/01/2006
Completion date02/01/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participants400
Key inclusion criteria1. 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 criteria1. 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 enrolment02/01/2006
Date of final enrolment02/01/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Churchill Hospital
Oxford
OX3 7LJ
United Kingdom

Sponsor information

Oxford Radcliffe Hospitals NHS Trust (UK)
Hospital/treatment centre

Research and Development Department
Manor House
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DZ
England
United Kingdom

ROR logo "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)
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 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 01/12/2012 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.