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

• Register: ANZCTR
• Last refreshed on: 4 April 2022
• Main ID: ACTRN12618000227291
• Date of registration: 12/02/2018
• Prospective Registration: Yes
• Primary sponsor: University of Adelaide
• Public title: An evaluation of the effectiveness of continuous positive airway pressure therapy in participants with obstructive sleep apnoea and angina
• Scientific title: A randomised evaluation of the effectiveness of continuous positive airway pressure therapy in participants with obstructive sleep apnoea and angina, and no obstructive coronary artery disease.
• Date of first enrolment: 14/02/2018
• Target sample size: 50
• Recruitment status: Stopped early
• URL: https://anzctr.org.au/ACTRN12618000227291.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Crossover;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Sharmalar Rajendran

• Name: Dr Sharmalar Rajendran

Key inclusion & exclusion criteria

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)

Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cardiovascular - Other cardiovascular diseases

Cardiovascular - Coronary heart disease

Respiratory - Sleep apnoea

Angina;Obstructive Sleep Apnoea;
Angina
Obstructive Sleep Apnoea

Intervention(s)

Participants with angina and no obstructive coronary artery disease from NOCAD1 study will be screened and recruited. Recruited participants will undergo type 2 ambulatory sleep study at participants' residence for the diagnosis of obstructive sleep apnoea.

Participants who have obstructive sleep apnoea and fulfilled the study inclusion/exclusion criteria as outlined for CPAP therapy will be randomly assigned to either "initial CPAP therapy" or "delayed CPAP therapy (no CPAP)" for 6 months, followed by crossover between group's therapy for further 6 months to assess the difference in effects on angina burden and quality of life.

Participants on CPAP therapy will received autoPAP (Philips Respironics, Murrayville, PA) for 1 week, followed by fixed CPAP pressure, set at 90th percentile of autoPAP pressure, as determined by Sleep Physician. Delivery of CPAP device and its accessories by Philips SleepEasy Device Consultant, including education and supports in conjunction with a Sleep Physician. This will take place at the Lyell McEwin Hospital Cardiology Clinical Trial Unit. Data will be available electronically via remote downloading using Encoreanywhere program. Participant's adherence is monitored by accessing device analytics which will be downloaded remotely. Satisfactory adherence towards CPAP therapy will be assessed by Sleep Physician at 1 months, 3 months and 6 months. Minimum amount of usage time should be > 4 hours per night. Participants will be contacted to troubleshoot any difficulties and if any problems arose.

There will be 6 months of no CPAP therapy prior to follow-up outcome assessment after cessation of CPAP therapy.

Primary Outcome(s)

Prevalence of obstructive sleep apnoea in participants with angina and no obstructive coronary artery disease.
The information will be obtained from type 2 ambulatory sleep study. [Within 4 weeks after coronary haemodynamics study.]

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.]

Secondary Outcome(s)

Central retinal vessel calibre (CRVC).
CRVC is obtained with Smartscope® Pro by Optomed will be used. (Non-mydriatic fundus camera)
[6 and 12 months after randomisation.]

Contractile reserve (CR).
CR is measured with strain imaging on low dose dobutamine stress echocardiography (DSE).[6 and 12 months after randomisation.]

Cardiovascular death.
The information will be obtained from linkage to medical records.[Over 12 months after randomisation.]

Stroke.
The information will be obtained from linkage to medical records.[Over 12 months after randomisation.]

Health Status.
This information obtained from EQ-5D questionnaires which is a standardized instrument for measuring generic health status.[6 and 12 months after randomisation.]

Aortic pulse wave velocity (PWV).
PWV is measured with TensioMed arteriography. [6 and 12 months after randomisation.]

Hospital admission with recurrent angina.
The information will be obtained from linkage to medical records.[Over 12 months after randomisation.]

Augmentation Index (Ax).
Ax is measured with TensioMed arteriography. [6 and 12 months after randomisation.]

Myocardial infarction.
The information will be obtained from linkage to medical records.[Over 12 months after randomisation.]

Secondary ID(s)

None

Source(s) of Monetary Support

Sleep and Respiratory Care, Philips Australia

Philips-Respironics Inc., a Philips Healthcare company.

Cardiology Unit, Lyell McEwin Hospital, Internal Research Fund

Ethics review

Status: Approved
Approval date: 18/12/2017
Contact:

TQEH/LMH/MH Human Research Ethics Committee and Northern Adelaide Local Health Network, NALHN Research Governance

Results

• Results available: Yes
• Date Posted: 28/03/2022
• Date Completed: 29/01/2021