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Clinical Trials/NCT01405976
NCT01405976
Completed
Not Applicable

Mid-and Long-term Efficacy of Ventilation Non-invasive and Continuos Positive Airway Pressure in Obesity Hypoventilation Syndrome

Sociedad Española de Neumología y Cirugía Torácica1 site in 1 country440 target enrollmentMay 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity Hypoventilation Syndrome
Sponsor
Sociedad Española de Neumología y Cirugía Torácica
Enrollment
440
Locations
1
Primary Endpoint
Days of hospitalization
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Primary objectives: evaluate the efficacy of noninvasive ventilation (NIV) treatment versus continuous positive airway pressure (CPAP) and life style modification treatment in Obesity Hypoventilation Syndrome (OHS), with PCO2 (first phase) and days of hospitalization (second phase) 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, echocardiography and the incidence and blood pressure 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 life style modification treatments. The AHI <=30 groups will be randomized to NIV or life style modification 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 Description

The AHI \>=30 group will be analyzed to CPAP, NIV or life style modification treatments for two mouths.Once an evaluation is done during this period, the life style modification treatment will be randomized with the NIV/CPAP treatment for a continuation of three years.

Registry
clinicaltrials.gov
Start Date
May 2009
End Date
July 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sociedad Española de Neumología y Cirugía Torácica
Responsible Party
Principal Investigator
Principal Investigator

Juan F. Masa

MD

Sociedad Española de Neumología y Cirugía Torácica

Eligibility Criteria

Inclusion Criteria

  • Age between 15 and 80 years old.
  • Absence of moderate or severe chronic obstructive pulmonary disease (COPD).
  • Absence of neuromuscular, chest wall or metabolic disease which cause daytime hypercapnia.
  • Absence of narcolepsy or restless legs syndrome
  • Exceed correctly treatment of at least 30 minutes with CPAP/NIV at wakefulness.

Exclusion Criteria

  • Psychophysical incapacity to answer questionnaires.
  • Patients who are not able to be evaluated by means of quality of life questionnaires for suffering restrictive chronic disease previously diagnosed (neoplasy, chronic pain of any origin, renal failure, severe chronic obstructive pulmonary disease and any other restrictive chronic disease).
  • Subjects with important chronic nasal obstruction that prevents from using CPAP/NIV.
  • Informed consent not obtained.

Outcomes

Primary Outcomes

Days of hospitalization

Time Frame: at least three years

Days of hospitalization

PaCO2

Time Frame: at the end of first two months

PaCO2

Secondary Outcomes

  • Number of Dropouts for Medical reasons and mortality(at least three years)
  • quality of life(two months and three years)
  • respiratory function(two months and three years)
  • polysomnographic parameters(two months)
  • molecular inflammation and endothelial dysfunction(two months and three years)
  • echocardiographic parameters(two months and three years)
  • Blood pressure and new cardiovascular events(three years)

Study Sites (1)

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