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CPAP in SAHS Patients With Hypertension (SAHS2-3)

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ClinicalTrials.gov Identifier: NCT02398032
Recruitment Status : Completed
First Posted : March 25, 2015
Last Update Posted : May 3, 2016
Sponsor:
Information provided by (Responsible Party):
Francisco Garcia-Rio, Hospital Universitario La Paz

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.


Condition or disease Intervention/treatment Phase
Sleep Apnea Syndromes Hypertension Device: CPAP nasal Device: sham CPAP nasal Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: CPAP nasal
Nasal continuous positive airway pressure, during the night
Device: CPAP nasal
During the night
Other Name: Nocturnal support with continuous positive airway pressure

Sham Comparator: sham CPAP nasal
Nasal sham continuous positive airway pressure, during the night
Device: sham CPAP nasal
During the night
Other Name: sham CPAP




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02398032


Locations
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Spain
Hospital Universitario La Paz
Madrid, Spain, 28034
Sponsors and Collaborators
Hospital Universitario La Paz
Investigators
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Principal Investigator: Francisco Garcia-Rio, MD Hospital Universitario La Paz, IdiPAZ
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Francisco Garcia-Rio, MD, Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT02398032    
Other Study ID Numbers: 99/0252
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: May 2016
Keywords provided by Francisco Garcia-Rio, Hospital Universitario La Paz:
sleep apnea
hypertension
mechanosensitivity
chemosensitivity
adhesion factors
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Hypertension
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases