CPAP in SAHS Patients With Hypertension

NCT02398032 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2016-05-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

CPAP nasal

During the night

DEVICE

sham CPAP nasal

During the night

Sponsors & Collaborators

  • Hospital Universitario La Paz

    lead OTHER

Principal Investigators

  • Francisco Garcia-Rio, MD · Hospital Universitario La Paz, IdiPAZ

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02398032 on ClinicalTrials.gov