ISRCTN - ISRCTN34164388: 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

Plain English Summary

http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=19

Trial website

Contact information

Type

Scientific

Primary contact

Prof John Stradling

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MOSAIC 1

Study information

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

Acronym

Multi-centre Obstructive Sleep Apnoea Interventional Cardiovascular Trial (MOSAIC)

Study hypothesis

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

Oxfordshire REC A, 15/12/2005, ref: 05/Q1604/159

Study design

Multi-centre randomised controlled

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Sleep apnoea

Intervention

Nasal CPAP machines versus no intervention

Intervention type

Device

Phase

Drug names

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 trial start date

02/01/2006

Overall trial end date

02/01/2009

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

400

Participant 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

Recruitment start date

02/01/2006

Recruitment end date

02/01/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Churchill Hospital
Oxford
OX3 7LJ
United Kingdom

Sponsor information

Organisation

Oxford Radcliffe Hospitals NHS Trust (UK)

Sponsor type

Government

Website

Funders

Funder type

Charity

Funder name

British Heart Foundation (UK) - PG/05/068

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location