CPAP in SAHS Patients With Hypertension (SAHS2-3)

Madrid Health Service

Status and phase

Completed

Phase 4

Conditions

Hypertension

Sleep Apnea Syndromes

Treatments

Device: CPAP nasal

Device: sham CPAP nasal

Study type

Interventional

Funder types

Other

Identifiers

NCT02398032

99/0252

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.