Clinical Trial: Alternative of Treatment in Obesity Hypoventilation Syndrome

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Mid-and Long-term Efficacy of Ventilation Non-invasive and Continuos Positive Airway Pressure in Obesity Hipoventilation Syndrome

Brief Summary: Primary objectives: evaluate the efficacy of noninvasive ventilation (NIV) treatment versus continuous positive airway pressure (CPAP) and the "historic" treatment (weight loss and oxygen) in Obesity Hipoventilation Syndrome (OHS), with PCO2 and days of hospitalization analyzed as a primary variables and percentage of dropouts for medical reasons and mortality as operative variables. As secondary variables: Measure functional and clinical improvement during sleep and wakefulness, quality of life, and the incidence and evolution of cardiovascular events. Objectives secondaries:role of apneogenic sleep events on molecular inflammation, endothelial damage and the genesis of diurnal hypercapnia. Methods:prospective, randomized controlled trial. Patients with OHS will be divided initially into two groups based on their apnea-hypopnea index (AHI) score, >=30 and < 30, using conventional polysomnography. The AHI >=30 group will be randomized to CPAP, NIV or historic treatment. The AHI <=30 groups will be randomized to NIV or historic treatments. Treatment efficacy at the medium- and long-term will be analyzed by comparing groups. The role of apneic events and leptin in the genesis of daytime alveolar hypoventilation will be analyzed by comparing the daytime PCO2/AHI coefficient between responders and non-responders to CPAP treatment, and the evolution of leptin levels in the four branches of the study. The role of apneic events in metabolic and biochemical alterations and endothelial dysfunction will be analyzed by comparing basal and post-treatment levels of related substances between groups, with and without significant AHI.

Detailed Summary: The AHI >=30 group will be analyzed to CPAP, NIV or historic treatment for two mouths.Once an evaluation is done during this period, the historical medical treatment will be randomized with the NIV/CPAP treatment for a continuation of three years.
Sponsor: Sociedad Española de Neumología y Cirugía Torácica

Current Primary Outcome: Days of hospitalization [ Time Frame: at the end of two months and three years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Number of Dropouts for Medical reasons and mortality [ Time Frame: two months, three years ]

Original Secondary Outcome: Same as current

Information By: Sociedad Española de Neumología y Cirugía Torácica

Dates:
Date Received: July 3, 2008
Date Started: November 2009
Date Completion: July 2016
Last Updated: April 19, 2016
Last Verified: December 2015