N/A N=83 Randomized Single-blind Treatment

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

Hypertension · Metabolic Disorder

Bottom Line

View on ClinicalTrials.gov: NCT02059993 ↗

Enrolled (actual)

Serious AEs

7.2%

Results posted

Apr 2015

Primary outcome: Primary: Change of Daytime Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Pre-treatment and Post-treatment — -8; -3; -4; -3 mm Hg — p=<0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: continuous positive airway pressure (Device)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: Chinese Pulmonary Vascular Disease Research Group
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Change of Daytime Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Pre-treatment and Post-treatment	-8; -3; -4; -3	<0.05 sig
SECONDARY Change in Epworth Sleepiness Scale (ESS)	7.0; 3.7	0.001 sig

Summary

Obstructive sleep apnea(OSA) is an important identifiable cause of hypertension. Previous study has suggested that OSA significantly increases cardiovascular morbidity and mortality, especially in patients with pre-existing cardiovascular disease.The standardized treatment of moderate/severe OSA is continuous positive airway pressure (CPAP). Most of short-term trials indicated that CPAP treatment reduced BP in patients with OSA. But relevant studies have a relative short duration with only but few more than one year. In our opinion, they are not sufficient to detect the real effect of CPAP on reduction in BP. Besides, the impact of OSA on metabolic disorder is still unclear.We hypothesized that long-term CPAP treatment could reduce blood pressure and improve metabolic disorder in patients with coronary heart disease (CHD)and OSA.

Eligibility Criteria

Inclusion Criteria

men and women, aged 45 to 75 years old
verified diagnosis of hypertension by medical history or receiving antihypertensive drugs
established diagnosis of CHD
at least 3-month optimal treatment for hypertension
moderate or severe OSA

Exclusion Criteria

if they had secondary hypertension
central sleep apneas
history of significant chronic renal, or hepatic failure or severe pulmonary disease
diagnosed with malignant cancer with a life expectancy of less than 2years
regular use of medications that can affect BP(including corticosteroids or sedative drugs)
severe psychiatric disease
sustained excessive alcohol use
current use of CPAP treatment for OSA or pharyngeal surgery for OSA
New York Heart Association Class III-IV degree
declined to participate or were unable to give informed consent

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Data sourced from ClinicalTrials.gov (NCT02059993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.