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Completed

NCT Number: NCT00843583

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Medicine, The University of Hong Kong, Queen Mary Hospital

Hong Kong, 852

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≧ 3 anti-HT drugs
  • age 18-65
  • mentally fit for signing an informed written consent

Exclusion criteria

  • moderate renal impairment (glomerular filtration rate <30 mL/min/m2 )
  • endocrine/renal/cardiac causes of secondary HT
  • congestive heart failure and clinically fluid overloaded
  • On drugs that elevate BP e.g. alcohol, NSAID, steroid

Treatment and study plan

Primary outcomes

  1. ambulatory blood pressure

    Time frame: 24 hour

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Feb 13, 2009
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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