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CPAP in SAHS Patients With Hypertension (SAHS2-3)

Primary Purpose

Sleep Apnea Syndromes, Hypertension

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
CPAP nasal
sham CPAP nasal
Sponsored by
Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea Syndromes focused on measuring sleep apnea, hypertension, mechanosensitivity, chemosensitivity, adhesion factors

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario La Paz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

CPAP nasal

sham CPAP nasal

Arm Description

Nasal continuous positive airway pressure, during the night

Nasal sham continuous positive airway pressure, during the night

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)
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
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
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)

Full Information

First Posted
April 1, 2013
Last Updated
May 2, 2016
Sponsor
Hospital Universitario La Paz
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1. Study Identification

Unique Protocol Identification Number
NCT02398032
Brief Title
CPAP in SAHS Patients With Hypertension
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario La Paz

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes, Hypertension
Keywords
sleep apnea, hypertension, mechanosensitivity, chemosensitivity, adhesion factors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPAP nasal
Arm Type
Experimental
Arm Description
Nasal continuous positive airway pressure, during the night
Arm Title
sham CPAP nasal
Arm Type
Sham Comparator
Arm Description
Nasal sham continuous positive airway pressure, during the night
Intervention Type
Device
Intervention Name(s)
CPAP nasal
Other Intervention Name(s)
Nocturnal support with continuous positive airway pressure
Intervention Description
During the night
Intervention Type
Device
Intervention Name(s)
sham CPAP nasal
Other Intervention Name(s)
sham CPAP
Intervention Description
During the night
Primary Outcome Measure Information:
Title
Effect of CPAP on the night-morning change in the withdrawal response and in the ventilatory and central drive responses to progressive isocapnic hypoxia.
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
CPAP effect on the night-morning change in the sniff diaphragmatic tension-time index
Description
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)
Time Frame
3 months
Title
CPAP effect on blood pressure
Description
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
Time Frame
3 months
Title
CPAP effect on the serum levels of endothelin-1 and vascular endothelial cell adhesion molecule (VCAM)-1
Description
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
Time Frame
3 months
Title
CPAP effect on the night-morning change in the rest metabolic rate
Description
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)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Garcia-Rio, MD
Organizational Affiliation
Hospital Universitario La Paz, IdiPAZ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28034
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
29146604
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.
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CPAP in SAHS Patients With Hypertension

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