Clinical trial NCT02398032: CPAP in SAHS Patients With Hypertension
Official title: CPAP Effect on Nocturnal Evolution of Chemosensitivity Determinants in Sleep Apnea-hypopnea Patients With Isolated Nocturnal Hypertension or Day-nigh Sustained Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Apnea Syndromes
Hypertension
Keywords: sleep apnea
hypertension
mechanosensitivity
chemosensitivity
adhesion factors
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2015-03-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Effect of CPAP on the night-morning change in the withdrawal response and in the ventilatory and central drive responses to progressive isocapnic hypoxia.
timeFrame: 3 months
Secondary outcomes:
measure: CPAP effect on the night-morning change in the sniff diaphragmatic tension-time index
timeFrame: 3 months
measure: CPAP effect on blood pressure
timeFrame: 3 months
measure: CPAP effect on the serum levels of endothelin-1 and vascular endothelial cell adhesion molecule (VCAM)-1
timeFrame: 3 months
measure: CPAP effect on the night-morning change in the rest metabolic rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Hospital Universitario La Paz, IdiPAZ
name: Francisco Garcia-Rio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Casitas R, Martinez-Ceron E, Galera R, Cubillos-Zapata C, Gonzalez-Villalba MJ, Fernandez-Navarro I, Sanchez B, Garcia-Sanchez A, Zamarron E, Garcia-Rio F. The effect of treatment for sleep apnoea on determinants of blood pressure control. Eur Respir J. 2017 Nov 16;50(5):1701261. doi: 10.1183/13993003.01261-2017. Print 2017 Nov.