CPAP in SAHS Patients With Hypertension

NCT02398032 | Completed Phase 4

• 1 other identifier: 99/0252
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea Syndromes; Hypertension

Keywords

sleep apnea; hypertension; mechanosensitivity; chemosensitivity; adhesion factors

Outcome Measures

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.

  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

Secondary Outcomes (4)

• 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

Study Arms (2)

CPAP nasal

EXPERIMENTAL

Nasal continuous positive airway pressure, during the night

Device: CPAP nasal

sham CPAP nasal

SHAM COMPARATOR

Nasal sham continuous positive airway pressure, during the night

Device: sham CPAP nasal

Interventions

CPAP nasal DEVICE

During the night

Also known as: Nocturnal support with continuous positive airway pressure

CPAP nasal

sham CPAP nasal DEVICE

During the night

Also known as: sham CPAP

sham CPAP nasal

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, 28034, Spain

Location

Related Publications (1)

• 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.

  PMID: 29146604 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Hypertension

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Francisco Garcia-Rio, MD

  Hospital Universitario La Paz, IdiPAZ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: March 25, 2015
• Study Start: May 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 3, 2016

Record last verified: 2016-05

Locations

ES (1)