Morbidity in Patients With Hypertension and Obstructive Sleep Apnea

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

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2020-12-31

Brief Summary

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MORPHEOS is a multicenter, randomized, unblinded study, for patients diagnosed with uncontrolled hypertension and at least one antihypertensive medication. Those patients with significant sleep apnea wil be randomized to CPAP or nasal strips for 6 months.

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Detailed Description

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Conditions

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Hypertension Sleep Apnea, Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Continuous positive airway pressure

Continuous positive airway pressure therapy (CPAP)

Group Type EXPERIMENTAL

CPAP

Intervention Type DEVICE

Nasal strips

Nasal strips applied to the outside surface of the nose with adhesive.

Group Type PLACEBO_COMPARATOR

CPAP

Intervention Type DEVICE

Interventions

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CPAP

Intervention Type DEVICE

Other Intervention Names

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Continuous positive airway pressure

Eligibility Criteria

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Inclusion Criteria

* Systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥ 90 mm Hg
* Current treatment with at least 1 antihypertensive drug

Exclusion Criteria

* Age \<18 and \>65 years
* BMI ≥ 40 kg/m2
* Heart failure, EF \< 45%, acute myocardial infarction, stroke, significant valvular dysfunction
* Chronic renal failure (serum creatinine \> 2 mg/dL)
* Use of cocaine, amphetamines, alcohol, illicit drugs
* Use of sympathomimetics (decongestants, appetite suppressants)
* Use of oral contraceptives and chronic use of NSAIDs
* Pregnancy
* Secondary causes of hypertension (other than sleep apnea)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No