SAHS2-3
CPAP Effect on Nocturnal Evolution of Chemosensitivity Determinants in Sleep Apnea-hypopnea Patients With Isolated Nocturnal Hypertension or Day-nigh Sustained Hypertension
Sponsor study identifier
interventional
32
1 country
1
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2016
Actual (reported)Study Completion
March 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2016
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2013
Actual (reported)May 2013
Date type not reportedThis date has not been verified as actual or estimated.
March 25, 2015
Actual (reported)March 2016
Actual (reported)March 2016
Actual (reported)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, %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
CPAP effect on the night-morning change in the sniff diaphragmatic tension-time index
3 months
CPAP effect on blood pressure
3 months
CPAP effect on the serum levels of endothelin-1 and vascular endothelial cell adhesion molecule (VCAM)-1
3 months
CPAP effect on the night-morning change in the rest metabolic rate
3 months
Nasal continuous positive airway pressure, during the night
Nasal sham continuous positive airway pressure, during the night
During the night
During the night
Hospital Universitario La Paz
Madrid, Madrid, 28034, Spain
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.
Francisco Garcia-Rio, MD
Hospital Universitario La Paz, IdiPAZ
32 participants (actual enrollment reported by the registry).
First Submitted
April 1, 2013
First Posted
March 25, 2015
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
March 2016
Actual (reported)Study Completion
March 2016
Actual (reported)Last Updated
May 3, 2016
Record last verified: 2016-05
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Source: ClinicalTrials.gov.
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