CPAP in SAHS Patients With Hypertension

Hypertension Clinical Trial

— SAHS2-3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02398032
• Other study ID #: 99/0252
• Status: Completed
• Phase: Phase 4
• First received: April 1, 2013
• Last updated: May 2, 2016
• Start date: May 2013
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Sleep Apnea Syndromes

Intervention

Device:
• CPAP nasal
During the night
• sham CPAP nasal
During the night

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of CPAP on the night-morning change in the withdrawal response and in the ventilatory and central drive responses to progressive isocapnic hypoxia.	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, %?V'I) and in the ventilatory and inspiratory neural drive responses to progressive isocapnic hypoxia (?V'I/arterial oxygen saturation (SaO2)/body surface area (BSA)] and ? occlusion pressure at 0.1 s (P0.1)/arterial oxygen saturation (SaO2), respectively).	3 months	No
Secondary	CPAP effect on the night-morning change in the sniff diaphragmatic tension-time index	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	No
Secondary	CPAP effect on blood pressure	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	No
Secondary	CPAP effect on the serum levels of endothelin-1 and vascular endothelial cell adhesion molecule (VCAM)-1	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	No
Secondary	CPAP effect on the night-morning change in the rest metabolic rate	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	No