CPAP in SAHS Patients With Hypertension (SAHS2-3)

May 2, 2016 updated by: Francisco Garcia-Rio, Hospital Universitario La Paz

CPAP Effect on Nocturnal Evolution of Chemosensitivity Determinants in Sleep Apnea-hypopnea Patients With Isolated Nocturnal Hypertension or Day-nigh Sustained Hypertension

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Hospital Universitario La Paz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPAP nasal
Nasal continuous positive airway pressure, during the night
Device: CPAP nasal
During the night
Other Names:
  • Nocturnal support with continuous positive airway pressure
Sham Comparator: sham CPAP nasal
Nasal sham continuous positive airway pressure, during the night
Device: sham CPAP nasal
During the night
Other Names:
  • sham CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of CPAP on the night-morning change in the withdrawal response and in the ventilatory and central drive responses to progressive isocapnic hypoxia.
Time Frame: 3 months
To compare the effect of three months of CPAP therapy versus sham CPAP on the night-morning (pre- vs. post-sleep) change in the withdrawal response (decrease in ventilation caused by two breaths of 100% oxygen, %ΔV'I) and in the ventilatory and inspiratory neural drive responses to progressive isocapnic hypoxia (ΔV'I/arterial oxygen saturation (SaO2)/body surface area (BSA)] and Δ occlusion pressure at 0.1 s (P0.1)/arterial oxygen saturation (SaO2), respectively).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CPAP effect on the night-morning change in the sniff diaphragmatic tension-time index
Time Frame: 3 months
To compare the effect of three months of CPAP therapy versus sham CPAP on the night-morning (pre- vs. post-sleep) change in the sniff diaphragmatic tension-time index (TTdi)
3 months
CPAP effect on blood pressure
Time Frame: 3 months
To compare the effect of three months of CPAP therapy on the blood pressure in SAHS patients with isolated nocturnal hypertension and SAHS patients with day-nigh sustained hypertension
3 months
CPAP effect on the serum levels of endothelin-1 and vascular endothelial cell adhesion molecule (VCAM)-1
Time Frame: 3 months
To compare the effect of three months of CPAP therapy versus sham CPAP on the serum levels of endothelin-1 and VCAM-1 in SAHS patients with isolated nocturnal hypertension and SAHS patients with day-nigh sustained hypertension
3 months
CPAP effect on the night-morning change in the rest metabolic rate
Time Frame: 3 months
To compare the effect of three months of CPAP therapy versus sham CPAP on the night-morning (pre- vs. post-sleep) change in the rest metabolic rate (carbon dioxide production/oxygen uptake ratio, RER)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario La Paz

Investigators

  • Principal Investigator: Francisco Garcia-Rio, MD, Hospital Universitario La PAZ, IdiPAZ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

April 1, 2013

First Submitted That Met QC Criteria

March 19, 2015

First Posted (Estimate)

March 25, 2015

Study Record Updates

Last Update Posted (Estimate)

May 3, 2016

Last Update Submitted That Met QC Criteria

May 2, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99/0252

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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