Effect of Continuous Positive Airway Pressure (CPAP) Versus Auto-titrating Continuous Positive Airway Pressure (APAP) on Resistant Hypertension (HTN) and Arterial Stiffness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2020-01-31

Brief Summary

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The primary objective is to evaluate the relative effectiveness of fixed CPAP in comparison to APAP in reducing arterial blood pressure in patients with resistant hypertension and obstructive sleep apnea (OSA).

The secondary objectives are: a) to evaluate the relative effectiveness of fixed CPAP versus APAP in improving arterial stiffness, sleep-disordered breathing, sleep quality, inflammatory markers and glucose regulation; b) to identify specific characteristic of persons who respond to the two CPAP modalities in order to identify which device is better for each subject.

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Detailed Description

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The confirmatory hypothesis is that subjects with resistant hypertension and OSA will show a greater degree of blood pressure reduction after 6 weeks of treatment with fixed CPAP in comparison to those treated with APAP. Explanatory and exploratory hypotheses are that a greater reduction in arterial stiffness will be noted when compared with the benefit in blood pressure, that reductions in arterial stiffness will be associated with benefits to serum measurements of inflammatory markers and glucose regulation, and that control of sleep apnea and the attendant improvement in sleep quality will be better with fixed CPAP than APAP.

Conditions

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Resistant Hypertension Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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auto-titrating

Patients being treated for 6 weeks with auto-titrating continuous airway pressure.

Group Type ACTIVE_COMPARATOR

APAP

Intervention Type DEVICE

6 weeks of treatment with auto-titrating positive airway pressure

Fixed

Patients receiving 6 weeks of treatment with fixed continuous positive airway pressure.

Group Type ACTIVE_COMPARATOR

CPAP

Intervention Type DEVICE

6 weeks treatment with fixed CPAP

Interventions

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CPAP

6 weeks treatment with fixed CPAP

Intervention Type DEVICE

APAP

6 weeks of treatment with auto-titrating positive airway pressure

Intervention Type DEVICE

Other Intervention Names

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Continuous Positive Airway Pressure auto-titrating airway pressure

Eligibility Criteria

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Inclusion Criteria

* Resistant Hypertension
* Moderate Obstructive Sleep Apnea

Exclusion Criteria

* Creatinine \>150 μmol/l
* Systolic blood pressure \> 170 mmHg
* Diastolic blood pressure \> 105 mmHg
* Secondary cause of hypertension other than OSA
* Treatment within the last 3 months or current treatment for sleep-disordered breathing or some other sleep disorder
* Current treatment or recent treatment within the last 3 months for any other medical condition which has resulted or would be expected to result in a change in blood pressure medications

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No