Effect of Treating Sleep Disorder Breathing in Patients With Resistant Hypertension

Study Overview
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Brief Summary
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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
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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: Ambulatory Autotitrating Positive Airway Pressure (APAP) plus Standard medical therapy OR 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.

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

Conditions
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Sleep Apnea, Hypertension

Intervention / Treatment
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* Device: Autotitrating Positive Airway Pressure (APAP)
* Device: Traditional Split Titration Polysomnogram


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ambulatory APAP and SMT<br>Subjects placed on the APAP machine | Device: Autotitrating Positive Airway Pressure (APAP)<br>* Then subjects will use Autotitrating Positive Airway Pressure machine for 90 days<br>|
| Other: Titration Polysomnogram with CPAP and SMT<br>Subjects placed on CPAP machine | Device: Traditional Split Titration Polysomnogram<br>* Then subjects will use Continuous Positive Airway Pressure (CPAP) machine for 90 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Disordered Breathing, Sleep Apnea, Hypertension, Continuous Positive Airway Pressure