CPAP in SAHS Patients With Hypertension

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

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-03-31

Brief Summary

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Study objective: To assess the nocturnal changes in mechanosensitivity and chemosensitivity in hypertensive sleep apnea-hypopnea syndrome (SAHS) patients and in SAHS patients with isolated nocturnal hypertension. To value the continuous positive airway pressure (CPAP) effect on these parameters.

Design: Controlled cross-over longitudinal study. Settings: Madrid metropolitan area. Patients: Day-night sustained hypertensive and isolated nocturnal hypertensive patients with SAHS without previous treatment. At least 30 patients are needed.

Interventions: Patients will allocate in each treatment arm (CPAP vs. sham CPAP) during three months. Explorations will perform before and immediately after sleep at 0-, 3-, and 6-months of trial.

Measurements: 24-h urinary catecholamine, local vascular factors, angiotensin and aldosterone levels. Diaphragmatic tension-time index, metabolic rate, hypoxic withdrawal test, and ventilatory and inspiratory neural drive responses to progressive isocapnic hypoxia.

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Detailed Description

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Conditions

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Sleep Apnea Syndromes Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CPAP nasal

Nasal continuous positive airway pressure, during the night

Group Type EXPERIMENTAL

CPAP nasal

Intervention Type DEVICE

During the night

sham CPAP nasal

Nasal sham continuous positive airway pressure, during the night

Group Type SHAM_COMPARATOR

sham CPAP nasal

Intervention Type DEVICE

During the night

Interventions

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CPAP nasal

During the night

Intervention Type DEVICE

sham CPAP nasal

During the night

Intervention Type DEVICE

Other Intervention Names

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Nocturnal support with continuous positive airway pressure sham CPAP

Eligibility Criteria

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Inclusion Criteria

* Recent diagnosis of sleep apnea-hypopnea syndrome with an apnea-hypopnea index (AHI) \> 10 h-1
* No previous treatment for SAHS or hypertension
* Diagnosis by 24-h ambulatory monitoring of blood pressure (AMBP) of isolated nocturnal hypertension (nighttime blood pressure of ≥120 mm Hg systolic or 70 mm Hg diastolic and a daytime blood pressure \<135/85 mm Hg) or day-night sustained hypertension (nighttime blood pressure of ≥120 mm Hg or 70 mm Hg diastolic and a daytime blood pressure of ≥135 mm Hg systolic).

Exclusion Criteria

* Severe hypertension (\> 180/120 mmHg).
* Previous diagnosis of secondary hypertension.
* Myocardial infarction or stroke in the last three months.
* Severe diurnal sleepiness (Epworth score \> 15)
* Previous diagnosis of chronic obstructive pulmonary disease, asthma, bronchiectasis, lung cancer, restrictive lung disease, chest wall disease or thoracic surgery.
* Previous diagnosis or clinical evidence of heart disease, neuromuscular disease or thyroid dysfunction.
* Morbid obesity (BMI \> 40 Kg/m2)
* Respiratory infection in the last two months.
* Treatment with theophylline or systemic corticosteroids in the last two years.
* Excessive alcohol intake (\>40 g/day)
* Absence of social or familiar support.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No