NCT00973531

Effect of Treating Sleep Disorder Breathing in Patients With Resistant Hypertension

Effect of Treating Sleep Disorder Breathing Therapy in Patients With Resistant Hypertension

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Albert Einstein Healthcare Network · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The investigators would like to investigate the effects of treating sleep apnea with a positive airway pressure device, either continuous (titrated) versus auto titrated on the control of blood pressure in patients with Resistant Hypertension.

Detailed description

One of the major cause and contributor to stroke, myocardial infarction, heart disease, and kidney disease is high blood pressure. Traditional approaches to control of hypertension (HTN) have mostly included pharmaceuticals targeting different mechanisms that contribute to HTN. However, adequate control of Blood pressure continues to remain a major problem. Sleep Apnea is currently being recognized as a modifiable risk factor for resistant HTN. Sleep disordered breathing represents states of increased sympathetic drive and vagal tone withdrawal, along with significant episodic hypoxia. There is increasing evidence that sleep apnea is highly prevalent in subjects with hypertension and may be a frequent cause of drug-resistant hypertension. We propose that we compare strategies for treating subjects with Resistant Hypertension who have SDB as detected by ambulatory multi somnogram and treat subjects using: 1. Ambulatory Autotitrating Positive Airway Pressure (APAP) plus Standard medical therapy OR 2. Traditional Polysomnogram and Traditional PSG guided titration of Continuous Positive Airway Pressure (CPAP) plus Standard medical therapy Our hypothesis is that in subjects with Resistant HTN, who have SDB, using the treatment approach of ambulatory multisomnography for testing and then treating with APAP will be noninferior to the traditional polysomnography plus CPAP approach in the amount of reduction of mean systolic and diastolic 24 hour ambulatory blood pressure, when treated for 90 days.

Conditions

• Sleep Apnea
• Hypertension

Interventions

Type	Name	Description
DEVICE	Autotitrating Positive Airway Pressure (APAP)	Then subjects will use Autotitrating Positive Airway Pressure machine for 90 days
DEVICE	Traditional Split Titration Polysomnogram	Then subjects will use Continuous Positive Airway Pressure (CPAP) machine for 90 days

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2009-09-09
• Last updated: 2012-01-26

Locations

1 site across 1 country: United States