Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000467730
Ethics application status
Approved
Date submitted
12/01/2022
Date registered
24/03/2022
Date last updated
16/05/2024
Date data sharing statement initially provided
24/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the effect of continuous positive airway pressure treatment on cardiopulmonary exercise capacity in Chinese patients with moderate to severe obstructive sleep apnea
Scientific title
Evaluation of the effect of continuous positive airway pressure treatment on cardiopulmonary exercise capacity in Chinese patients with moderate to severe obstructive sleep apnea
Secondary ID [1] 306197 0
Nil known
Universal Trial Number (UTN)
U1111-1273-2027
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obstructive sleep apnea 324903 0
Condition category
Condition code
Respiratory 322341 322341 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Recruited subjects with moderate and severe obstructive sleep apnea (OSA) first receive investigations including polysomnography, cardiopulmonary exercise test, spirometry, echocardiography, blood test and chest X ray. Afterwards, they will receive three months continuous positive airway pressure (CPAP) treatment which is a standard management (Not experimental/new treatment). Participants would have received continuous positive airway pressure treatment regardless of their involvement in the study. After three months treatment, they will receive their second cardiopulmonary exercise test.

CPAP titration may be performed in the sleep laboratory or in home settings. For in-laboratory PAP titration, an attended titration using a Philips Respironics DreamStation Auto CPAP or a Resmed Airsense 10 Autoset for autotitration under polysomnography (PSG) guidance will be performed. PAP pressure that can abolish respiratory events during supine REM sleep with good leakage control will be set as the treatment pressure.

For home PAP titration, a Resmed Airsense 10 Autoset will be used for one week. Telemonitoring and daily phone contact will be conducted by trained nurses to optimize PAP usage and to perform trouble-shooting if needed. At the end of titration period, average 95% pressure with AHI less than 5/hr, good oxygen saturation and acceptable leakage will be set as the treatment pressure. If patient failed to achieve good control during home PAP titration, in-laboratory PAP titration till be arranged. Patients will be allowed to use fixed CPAP or autoCPAP according to their preferences after titration. The planned CPAP treatment would be every night over a period of at least 4 hours during sleep for a total duration of 3 months.

Two sessions will be conducted as follow-up. The first session is a 30-minute face-to-face follow up conducted by respiratory nurses 6 weeks after CPAP titration to assess the following: whether patient has started PAP treatment; treatment compliance (An acceptable compliance will be defined as more than 4hr usage per night and 5-7 nights per week); treatment efficacy (Good treatment efficacy will be defined as average AHI < 5 per hour). If patient’s PAP machine cannot generate compliance report, an overnight oximetry will be performed. Good treatment efficacy will be defined as oxygen desaturation index (ODI) < 5 per hour. Trouble-shooting will be performed if patient cannot achieve good treatment compliance and efficacy.

The second session is also a face-to-face appointment conducted by respiratory physicians and respiratory nurses 6 weeks after the first session to reassess parameters aforementioned. The second CPET will be arranged for participants that can achieve good treatment compliance and efficacy with CPAP.


Intervention code [1] 322601 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330103 0
Exercise capacity determined as the peak oxygen consumption rate (VO2, in ml/min/kg) by cardiopulmonary exercise test
Timepoint [1] 330103 0
Baseline, three months post-CPAP commencement
Secondary outcome [1] 404898 0
-Oxygen consumption rate (VO2, in ml/min/kg) at anaerobic threshold using cardiopulmonary exercise test (CPET)
Timepoint [1] 404898 0
Baseline, three months post-CPAP commencement
Secondary outcome [2] 407377 0
-Heart rate recovery after CPET using cardiac chest lead monitor
Timepoint [2] 407377 0
Baseline, 3 months post CPAP commencement
Secondary outcome [3] 407378 0
-Blood pressure recovery after CPET using sphygmomanometer
Timepoint [3] 407378 0
Baseline, 3 months post CPAP commencement
Secondary outcome [4] 407379 0
-Peak heart rate during CPET using cardiac chest lead monitor
Timepoint [4] 407379 0
Baseline, 3 months post CPAP commencement
Secondary outcome [5] 407380 0
-Peak blood pressure during CPET using sphygmomanometer
Timepoint [5] 407380 0
Baseline, 3 months post CPAP commencement
Secondary outcome [6] 407381 0
-Peak workload using CPET determined by ergometry machine used for CPET
Timepoint [6] 407381 0
Baseline, 3 months post CPAP commencement
Secondary outcome [7] 407382 0
-Oxygen pulse (oxygen consumption rate divided by heart rate) using CPET and cardiac chest lead monitor
Timepoint [7] 407382 0
Baseline, 3 months post CPAP commencement
Secondary outcome [8] 407383 0
-Ventilatory efficiency (minute ventilation per unit of carbon dioxide production) using CPET.
Timepoint [8] 407383 0
Baseline, 3 months post CPAP commencement

Eligibility
Key inclusion criteria
a) Chinese patients
b) 18 – 70 years old
c) Newly diagnosed with moderate to severe OSA confirmed by polysomnography (PSG)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Pre-existing known pulmonary/cardiac diseases
b) Left ventricular ejection fraction (LVEF) <50% or significant valvular disease detected in echocardiogram
c) Ethnicity other than Chinese
d) Invalid informed consent
e) Previously or currently on OSA treatment (CPAP/Oral appliance/Surgical treatment)
f) Sleep disorder other than OSA (e.g. central sleep apnea)
g) Obesity hypoventilation syndrome
h) Contraindication to CPAP treatment
i) Contraindication to cardiopulmonary exercise test
j) Known thyroid/renal/hepatic/neurological disease
k) Known musculoskeletal disorder
l) Mentally incapable
m) Anaemia
n) Peripheral vascular disease
o) Alcohol/substance abuse
p) Current medication including sedatives/sympathomimetics
q) Acute respiratory/cardiovascular event within six weeks of cardiopulmonary exercise test

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be used to summarize the baseline patients’ demographic characteristics and expressed as mean +/- SD (standard deviation) or percentages as appropriate. Comparison of continuous variables will be performed by paired sample t test or Wilcoxon signed rank test depending whether the variables are normally distributed. Comparison of categorical variables will be performed by the Chi-square test or Fisher’s exact test as appropriate. Comparison of continuous variables between the pre-CPAP treatment and post-CPAP treatment group will be performed by repeated measure ANCOVA adjusted for covariates such as pre-treatment V’O2 value, and physical activity level. The results of the study will be analyzed using the computer software Statistical Package for Social Sciences (SPSS, Version 22, for Windows).

Sample size calculation is based on a study in 2020 of similar design regarding the change of maximal VO2 at a two tailed alpha level 0.05 and power 90% by the software G*Power 3.1.9.4. 10.7% patients of our sleep laboratory who were lost to follow up or refused CPAP treatment in 3 months after their OSA diagnosis will also be taken into consideration. After considering the attrition rate, 60 patients will be needed in the current study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2022
Actual
1/07/2022
Date of last participant enrolment
Anticipated
1/04/2026
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
60
Accrual to date
24
Final
Recruitment outside Australia
Country [1] 24492 0
Hong Kong
State/province [1] 24492 0

Funding & Sponsors
Funding source category [1] 310536 0
Self funded/Unfunded
Name [1] 310536 0
Unfunded
Country [1] 310536 0
Primary sponsor type
Individual
Name
Cheng Hei Shun
Address
Pamela Youde Nethersole Eastern Hospital, 3 Lok Man Road, Chai Wan, Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 311710 0
None
Name [1] 311710 0
Address [1] 311710 0
Country [1] 311710 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310158 0
Cluster Research Ethics Committee/Institutional Review Board (Hong Kong East Cluster)
Ethics committee address [1] 310158 0
Pamela Youde Nethersole Eastern Hospital, 3 Lok Man Road, Chai Wan, Hong Kong
Ethics committee country [1] 310158 0
Hong Kong
Date submitted for ethics approval [1] 310158 0
29/12/2021
Approval date [1] 310158 0
10/03/2022
Ethics approval number [1] 310158 0

Summary
Brief summary
The study purpose is to evaluate the effect of 3 months CPAP treatment on exercise capacity of OSA patients. The study hypothesis is that exercise capacity of Chinese patients with moderate to severe OSA regardless of obesity status will be improved after CPAP treatment.

Cardiopulmonary exercise test will be used to estimate the exercise capacity while polysomnography will be used for OSA diagnosis.


Cardiopulmonary exercise test (CPET) is a safe investigation that has been used as a prognostic assessment in heart disease. In the past decade, there has been a growing interest in applying CPET on evaluation of exercise capacity and cardiovascular risk in OSA patients. Several studies showed that OSA patients had lower peak oxygen consumption rate (V’O2 in ml/min/kg), greater diastolic blood pressure at maximal exercise and reduced heart rate recovery than control group and these findings are linked to increased cardiovascular risk.

Continuous positive airway pressure (CPAP) is a treatment of OSA that was found to improve maximal exercise response by increasing peak V’O2, heart rate recovery and blood pressure recovery. It was therefore postulated that CPAP treatment could reduce cardiovascular risk in OSA patients. Nevertheless, majority of these studies were done on obese Caucasian population and few are on Chinese ethnicity or non-obese OSA patients. The obesity definitions are different between Caucasian and Chinese population and previous studies results may not be totally applicable to Chinese patients with OSA. In obese population, the total body weight that was used in previous studies may be inaccurate compared with fat free mass (FFM) which is important especially during exercise test. FFM may provide a better estimation. Besides, one meta-analysis found that non-obese OSA patients (BMI <30 kg/m2) had higher degree of peak V’O2 reduction than obese OSA patients and therefore evaluating CPAP effect on this group of patients is valuable.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116690 0
Dr Cheng Hei Shun
Address 116690 0
Pamela Youde Nethersole Eastern Hospital, 3 Lok Man Road, Chai Wan, Hong Kong
Country 116690 0
Hong Kong
Phone 116690 0
+852 64600207
Fax 116690 0
Email 116690 0
chenghilson@gmail.com
Contact person for public queries
Name 116691 0
Dr Cheng Hei Shun
Address 116691 0
Pamela Youde Nethersole Eastern Hospital, 3 Lok Man Road, Chai Wan, Hong Kong
Country 116691 0
Hong Kong
Phone 116691 0
+852 64600207
Fax 116691 0
Email 116691 0
chenghilson@gmail.com
Contact person for scientific queries
Name 116692 0
Dr Cheng Hei Shun
Address 116692 0
Pamela Youde Nethersole Eastern Hospital, 3 Lok Man Road, Chai Wan, Hong Kong
Country 116692 0
Hong Kong
Phone 116692 0
+852 64600207
Fax 116692 0
Email 116692 0
chenghilson@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14647Study protocol    383408-(Uploaded-12-01-2022-16-34-07)-Study-related document.docx
14649Informed consent form    383408-(Uploaded-12-01-2022-16-35-14)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.