Obstructive Sleep Apnea Clinical Trial
Official title:
A Cross-sectional Study of the Occurrence and Effect of Obstructive Sleep Apnea in Subjects With Resistant Hypertension
This study aims to investigate the prevalence of obstructive sleep apnea (OSA) in subjects with resistant hypertension and to evaluate the relationship between parameters of OSA severity and blood pressure control
Obstructive sleep apnea (OSA) is characterized by intermittent upper airway collapse during
sleep, which results in hypoxia, arousals and surge in sympathetic activity. There is robust
evidence to support a contributing role of OSA in hypertension (HT). The Sleep Heart Health
Study (1), which recruited more than 6000 subjects having polysomnogram at home, found an
independent association between OSA and HT. The adjusted odds ratio was 1.37 for subjects
with and apnea-hypopnea index >= 30/hour compared to those without apnea. The Wisconsin
Sleep Cohort Study , which provided prospective longitudinal follow-up for OSA subjects over
4 years, have shown dose dependency of the severity of OSA and the risk of development of
HT. Current available data suggests that in hypertensive patients with severe OSA, there is
a BP drop of about 10mmHg with CPAP treatment (2-5). The blood pressure (BP) lowering effect
of CPAP treatment in the group with mild asymptomatic OSA is less consolidated.
The relationship between BP and risk of cardiovascular events is continuous, consistent, and
independent of other risk factors. A strict blood pressure control is imperative in subjects
with diabetes mellitus or renal impairment. Resistant hypertension is defined as blood
pressure that remains above goal in spite of concurrent use of 3 antihypertensive agents of
different classes. (6) Resistant hypertension is defined in order to identify patients who
are at risk of having secondary causes of hypertension, and who may benefit from specific
diagnostic and therapeutic applications. Despite the fact that OSA is listed as one of the
causes of resistant HT (6), paucity of works has demonstrated the scale of problems of
untreated OSA in subjects with resistant HT. (7-9) There is so far one study demonstrating
the beneficial effect of CPAP treatment in subjects with resistant HT, though no
randomization was implemented and the sample size was limited (n=11). (10) We aim at
conducting a cross-sectional study to explore the situation which would guide further
clinical trial.
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