An interventional study of Autotitrating Positive Airway Pressure (APAP) and Traditional Split Titration Polysomnogram in Sleep Apnea and Hypertension, sponsored by Albert Einstein Healthcare Network. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-01-26.
Sponsored by Albert Einstein Healthcare Network · Not applicable, Interventional, and Treatment
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.
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:
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.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.
Browse Sleep Apnea Syndromes studies →Albert Einstein Healthcare Network is the lead sponsor of 63 studies on the registry; 6 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
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Exclusion Criteria:
Subjects taking over the counter medications that can raise blood pressure, such as
Subjects placed on the APAP machine
Device: Autotitrating Positive Airway Pressure (APAP)
Subjects placed on CPAP machine
Device: Traditional Split Titration Polysomnogram
Then subjects will use Autotitrating Positive Airway Pressure machine for 90 days
Then subjects will use Continuous Positive Airway Pressure (CPAP) machine for 90 days
Noninferiority of the change from baseline to 90 day measurement in mean ambulatory 24-hour systolic ambulatory blood pressure in the Newer approach v/s Traditional Approach
Time frame: 90 days
Noninferiority of the change from baseline to 90 day measurement in mean ambulatory 24-hour diastolic ambulatory blood pressure in the Newer approach v/s Traditional Approach
Time frame: 90 days
This study is withdrawn, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Albert Einstein Healthcare Network