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Completed

NCT Number: NCT02398032

CPAP in SAHS Patients With Hypertension

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.

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Key information

Conditions

Sleep Apnea Syndromes Apnea Cardiovascular Diseases Dyssomnias Hypertension Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario La Paz

Madrid, 28034, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CPAP nasal

Device

During the night

Other names: Nocturnal support with continuous positive airway pressure

sham CPAP nasal

Device

During the night

Other names: sham CPAP

Primary outcomes

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

    Time frame: 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 outcomes

  1. CPAP effect on the night-morning change in the sniff diaphragmatic tension-time index

    Time frame: 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)

  2. CPAP effect on blood pressure

    Time frame: 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

  3. CPAP effect on the serum levels of endothelin-1 and vascular endothelial cell adhesion molecule (VCAM)-1

    Time frame: 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

  4. CPAP effect on the night-morning change in the rest metabolic rate

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Paz

Other

Registry information

Official study title

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

Acronym: SAHS2-3

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 25, 2015
Registry last updated
May 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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