CPAP in SAHS Patients With Hypertension

Phase 4

Completed

• Conditions: Hypertension; Sleep Apnea Syndromes
• Interventions: Device: CPAP nasal; Device: sham CPAP nasal

• Registration Number: NCT02398032
• Lead Sponsor: Hospital Universitario La Paz

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-01
• Study Start: 2013-05
• Study First Submitted QC: 2015-03-19
• Study First Posted: 2015-03-25
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-02
• Last Update Posted: 2016-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CPAP nasal	CPAP nasal	Nasal continuous positive airway pressure, during the night
sham CPAP nasal	sham CPAP nasal	Nasal sham continuous positive airway pressure, during the night

Primary Outcome Measures

Name	Time	Method
Effect of CPAP on the night-morning change in the withdrawal response and in the ventilatory and central drive responses to progressive isocapnic hypoxia.	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).

Secondary Outcome Measures

Name	Time	Method
CPAP effect on the night-morning change in the sniff diaphragmatic tension-time index	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)
CPAP effect on blood pressure	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
CPAP effect on the serum levels of endothelin-1 and vascular endothelial cell adhesion molecule (VCAM)-1	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
CPAP effect on the night-morning change in the rest metabolic rate	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)

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain