Hypertension, Sleep Apnea
Conditions
Keywords
Sleep Disordered Breathing, Sleep Apnea, Hypertension, Continuous Positive Airway Pressure
Brief 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.
Interventions
DEVICEAutotitrating Positive Airway Pressure (APAP)
Then subjects will use Autotitrating Positive Airway Pressure machine for 90 days
DEVICETraditional Split Titration Polysomnogram
Then subjects will use Continuous Positive Airway Pressure (CPAP) machine for 90 days
Sponsors
Albert Einstein Healthcare Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who are competent to provide written consent * Aged 18 to 80 years * Deemed to be compliant with anti-hypertension medication therapy. * Subjects with diabetes and/or chronic kidney disease must have a mean 24 hour systolic blood pressure ≥130 mmHg * All other subjects must have a mean 24 hour systolic blood pressure ≥140 mmHg * Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, preferably including a diuretic
Exclusion criteria
* Average sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg * Known Sleep apnea * Subjects who perform alternating shift or night work * Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening * Have hypertension secondary to an identifiable and treatable cause other than sleep apnea * Subjects taking over the counter medications that can raise blood pressure, such as * Non narcotic analgesics * Non steroidal anti-inflammatory agents, including aspirin, Selective COX-2 inhibitors * Sympathomimetic agents (decongestants, diet pills, cocaine) * Stimulants (methylphenidate, dexmethylphenidate, dextroamphetamine, amphetamine, methamphetamine, modafinil) * Alcohol * Oral contraceptives * Cyclosporine * Erythropoietin * Natural licorice * Herbal compounds (ephedra or ma huang)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 90 days |
Countries
United States
Outcome results
None listed