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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN34164388

Enrollment

400

Registered

2005-10-05

Start date

2006-01-02

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

Sleep apnoea Nervous System Diseases Sleep apnoea

Interventions

Nasal CPAP machines versus no intervention

Eligibility

Sex/Gender

Male

Inclusion criteria

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

Exclusion criteria

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 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 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

Design outcomes

Primary

Measure	Time frame
1. Reduction in the cardiovascular risk using the Framingham score 2. Reduction in Epworth Sleepiness Score	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 2, 2026