Trial Outcomes & Findings for The Effects of Obstructive Sleep Apnea and Its Intervention on Coronary Heart Disease (NCT NCT02059993)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

83 participants

Primary outcome timeframe

baseline and follow-up at 36 months

Results posted on

2020-07-16

Participant Flow

We recruited consecutive patients from outpatient and inpatient departments of Fuwai Hospital from January 2009 to June 2012. Patients were randomly assigned to either continuous positive airway pressure (CPAP) group or no CPAP therapy (control).

A total of 243 patients were screened between January 2009 and June 2012. Out of 97 (39.9%) patients diagnosed with obstructive sleep apnea (OSA), 5 subjects declined to participate in the study, and 9 subjects were excluded because of the following: apnea-hypopnea index (AHI) \<15 (n = 8 patients) and severe heart failure (n = 1 patient).

Participant milestones

Participant milestones
Measure	Continuous Positive Airway Pressure(CPAP) Group The continuous positive airway pressure group received fixed-level continuous positive airway pressure titration using an automated pressure and the the cardiovascular drugs based on the guidelines.	Control The controls only received the cardiovascular drugs based on the guidelines but without continuous positive airway pressure machine.
Overall Study STARTED	42	41
Overall Study COMPLETED	40	37
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Obstructive Sleep Apnea and Its Intervention on Coronary Heart Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Continuous Positive Airway Pressure(CPAP) Group n=42 Participants The CPAP group received fixed-level CPAP titration using an automated pressure setting device for one night. The optimal CPAP pressure for each patient in the CPAP group was set at the minimum pressure required to abolish snoring, obstructive respiratory events, and airflow limitation for 95% of the night.	Control n=41 Participants The control group received the standardized antihypertensive medications but without receiving CPAP machine.	Total n=83 Participants Total of all reporting groups
Age, Continuous	62.0 years STANDARD_DEVIATION 6.8 • n=39 Participants	62.7 years STANDARD_DEVIATION 6.7 • n=41 Participants	62.4 years STANDARD_DEVIATION 6.6 • n=35 Participants
Sex: Female, Male Female	12 Participants n=39 Participants	10 Participants n=41 Participants	22 Participants n=35 Participants
Sex: Female, Male Male	30 Participants n=39 Participants	31 Participants n=41 Participants	61 Participants n=35 Participants
Region of Enrollment China	42 participants n=39 Participants	41 participants n=41 Participants	83 participants n=35 Participants
morning systolic and diastolic BP (mmHg) systolic BP	146 mm Hg STANDARD_DEVIATION 8 • n=39 Participants	148 mm Hg STANDARD_DEVIATION 11 • n=41 Participants	147 mm Hg STANDARD_DEVIATION 9 • n=35 Participants
morning systolic and diastolic BP (mmHg) diastolic BP	83 mm Hg STANDARD_DEVIATION 7 • n=39 Participants	83 mm Hg STANDARD_DEVIATION 8 • n=41 Participants	83 mm Hg STANDARD_DEVIATION 7 • n=35 Participants

PRIMARY outcome

Timeframe: baseline and follow-up at 36 months

Population: 4 participants withdrew before the end of study. Two subjects were lost to follow-up in the control group, and 4 patients (all of them had no SCCE) with very poor CPAP compliance were also excluded.

Outcome measures

Outcome measures
Measure	Continuous Positive Airway Pressure(CPAP) Group n=36 Participants The subjects who received CPAP treatment and standardized medicine.	Control n=37 Participants The patients who use standardized drugs without CPAP machine.
Change of Daytime Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Pre-treatment and Post-treatment Change of SBP	-8 mm Hg Standard Deviation 11	-3 mm Hg Standard Deviation 6
Change of Daytime Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Pre-treatment and Post-treatment Change of DBP	-4 mm Hg Standard Deviation 11	-3 mm Hg Standard Deviation 11

SECONDARY outcome

Timeframe: baseline，end of study ( up to 54 months)

The epworth sleepiness scale（ESS） measures a person's general level of daytime sleepiness, or their average sleep propensity in daily life (ASP). It is a simple questionnaire based on retrospective reports of the likelihood of dozing off or falling asleep in a variety of different situations. The ESS is the most commonly used method for measuring a person's ASP.The ESS ranges from 0-24, higher scores indicate more severe daytime sleepiness.

Outcome measures

Outcome measures
Measure	Continuous Positive Airway Pressure(CPAP) Group n=36 Participants The subjects who received CPAP treatment and standardized medicine.	Control n=37 Participants The patients who use standardized drugs without CPAP machine.
Change in Epworth Sleepiness Scale (ESS)	7.0 score on a scale Standard Deviation 3.4	3.7 score on a scale Standard Deviation 2.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 1 month, 3 month, 6 month, 12 month, 18 month, 24 month, 30 month, 36 month

Outcome measures

Outcome data not reported

Adverse Events

Continuous Positive Airway Pressure(CPAP) Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Continuous Positive Airway Pressure(CPAP) Group n=42 participants at risk The CPAP group received fixed-level CPAP titration using an automated pressure setting device for 1 night. The optimal CPAP pressure for each patient in the CPAP group was set at the minimum pressure required to abolish snoring, obstructive respiratory events, and airflow limitation for 95% of the night.	Control n=41 participants at risk The control subjects received standardised anti-hypertension medications according to the current guildline.
Cardiac disorders acute myocardial infarction	0.00% 0/42 • 3 years SCCEs included new-onset acute myocardial infarction (AMI), hospitalization for heart failure, need for repeated coronary revascularization, stroke, and death associated with cardiovascular and cerebrovascular disease.	4.9% 2/41 • Number of events 2 • 3 years SCCEs included new-onset acute myocardial infarction (AMI), hospitalization for heart failure, need for repeated coronary revascularization, stroke, and death associated with cardiovascular and cerebrovascular disease.
Cardiac disorders heart failure	2.4% 1/42 • Number of events 1 • 3 years SCCEs included new-onset acute myocardial infarction (AMI), hospitalization for heart failure, need for repeated coronary revascularization, stroke, and death associated with cardiovascular and cerebrovascular disease.	0.00% 0/41 • 3 years SCCEs included new-onset acute myocardial infarction (AMI), hospitalization for heart failure, need for repeated coronary revascularization, stroke, and death associated with cardiovascular and cerebrovascular disease.
Nervous system disorders stroke	0.00% 0/42 • 3 years SCCEs included new-onset acute myocardial infarction (AMI), hospitalization for heart failure, need for repeated coronary revascularization, stroke, and death associated with cardiovascular and cerebrovascular disease.	7.3% 3/41 • Number of events 3 • 3 years SCCEs included new-onset acute myocardial infarction (AMI), hospitalization for heart failure, need for repeated coronary revascularization, stroke, and death associated with cardiovascular and cerebrovascular disease.

Other adverse events

Adverse event data not reported

Additional Information

Zhihong Liu

State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Phone: +86-01088398196

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place