A randomised clinical trial to evaluate the effects of continuous positive airway pressure (CPAP) on nocturnal beat to beat blood pressure and vascular functio

Not Applicable

Recruiting

• Conditions: Obstructive sleep apnoea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12616001153404
• Lead Sponsor: The University of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Participants will be individuals with obstructive sleep apnoea and who have been established on Continuous positive airway pressure (CPAP) therapy within the last three years. They will also need to be compliant with CPAP therapy (average nightly use > 4 hours per night at the last review). Only participants whose CPAP therapy has been shown to be effective (i.e., residual AHI <10/hr on CPAP machine download or polysomnographic assessment of control of OSA while using CPAP) will be included.

Exclusion Criteria

1. Current smoker
2. Alcohol consumption more than 21 standard units per week
3. Significant cardiovascular disease including unstable angina, cardiac failure (NYHA > level 2), important arrhythmia (e.g. atrial fibrillation (AF), 2nd, 3rd degree heart block), history of myocardial infarction (MI) within last 3 months and previous history of stroke.
4. Severely and inadequately controlled hypertension (i.e. BP >180/110 mmHg).
5. Severe respiratory disease but excluding those with more than moderate obstructive lung disease i.e. reduced ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC ratio) and FEV1 < 50% or moderate restrictive lung disease i.e. FVC or total lung capacity (TLC < 50%). However stable lung disease with less severe disease can be recruited.
6. Severe nocturnal desaturation documented on polysomnography (PSG) > 2% night sleep-time with arterial oxygen saturation of <85%.
7. Central (non-obstructive) sleep apnoea (central events > 50% AHI or > 15 events/hour).
8. Predominant Cheyne-Stokes respiration.
9. Other serious medical disorders (disabling neurological disorders, life threatening malignancy, renal failure requiring dialysis, peripheral artery diseases and etc.)
10. Change of medication in the last 3 months
11. Morbid obesity (BMI> 40kg/m2).
12. OSA not primary sleep disorder, i.e. exclude if primary insomnia diagnosis, narcolepsy or primary restless legs/ periodic limb movement syndrome (PLMS).
13. Professional drivers.
14. Raynaud's phenomenon.

Study & Design

• Study Type: Interventional
• Study Design: Not specified