An evaluation of the effectiveness of continuous positive airway pressure therapy in participants with obstructive sleep apnoea and angina

Not Applicable

• Conditions: Angina; Obstructive Sleep Apnoea; Cardiovascular - Coronary heart disease; Respiratory - Sleep apnoea; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12618000227291
• Lead Sponsor: niversity of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-12
• Study Completion: 2021-01-29
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Met NOCAD1 study inclusion criteria:
- Clinical diagnosis of angina
- Persistent angina
- Coronary angiography demonstrating normal or no obstructive coronary disease (<50% diameter stenosis)

2. Participants for CPAP therapy with obstructive sleep apnoea diagnosis
- AHI>20
- AHI<20; REM-AHI>45

3. Patients are able and willing to give appropriate informed consent.

Exclusion Criteria

1. Met NOCAD1 study exclusion criteria:
- Admission for an acute coronary syndrome within the preceding month
- Prior coronary artery bypass grafting
- Contra-indications to coronary haemodynamic assessment - patients with permanent pacemaker or de brillator, severe renal or hepatic insu ciency, severe asthma, left ventricular systolic dysfunction (ejection fraction <50%)
- Alternative coronary explanations for the chest pain - obstructive coronary artery disease (Flow limiting coronary stenosis i.e. derived fractional flow reserve (FFR) <0.80), spontaneous coronary spasm (but not catheter related spasm), spontaneous coronary artery dissection
- Other cardiovascular disorders - pulmonary hypertension, pulmonary embolism, hypertrophic cardiomyopathy, or valvular heart disease.
2. Non-English speaking patient
3. Unable to give consent due to cognitive impairment
4. Patient is or may be pregnant
5. Severe comorbidity with severe disability or likelihood of death
6. Significant memory, perceptual or behavioural disorder
7. Neurological deficit preventing self administration of CPAP mask
8. Contra-indication to CPAP use e.g. pneumothorax
9. Severe respiratory disease defined as
- Severe chronic obstructive pulmonary disease (FEV1/FVC<70% and FEV1 <50% predicted)
- Resting SaO2 <90%.
10. Prior use of CPAP treatment of OSA
11. Increased risk of a sleep-related accident and/or excessive daytime sleepiness, defined by any one of the following:
- Driver occupation (eg truck, taxi)
- ‘fall asleep’ accident or ‘near miss’ accident in previous 12 months
- High Epworth Sleepiness Scale score (>15)
12. Severe nocturnal desaturation documented during sleep study as >10% overnight recording time with arterial oxygen saturation of <80%
13. Cheyne-Stokes Respiration (CSResp)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrent angina which is defined as one or more episodes of pain per week determined from the Seattle Angina Questionnaire.[6 and 12 months after randomisation.];Prevalence of obstructive sleep apnoea in participants with angina and no obstructive coronary artery disease. <br>The information will be obtained from type 2 ambulatory sleep study. [Within 4 weeks after coronary haemodynamics study.]