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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambulatory APAP and SMT | Other | Subjects placed on the APAP machine |
|
| Titration Polysomnogram with CPAP and SMT | Other | Subjects placed on CPAP machine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autotitrating Positive Airway Pressure (APAP) | Device | Then subjects will use Autotitrating Positive Airway Pressure machine for 90 days |
|
| 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 |
| 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 |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Darshak Karia, MD | Albert Einstein Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| Traditional Split Titration Polysomnogram | Device | Then subjects will use Continuous Positive Airway Pressure (CPAP) machine for 90 days |
|
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |