Alternative of Treatment in Obesity Hypoventilation Syndrome

This study is currently recruiting participants.
Verified December 2012 by Sociedad Española de Neumología y Cirugía Torácica
Sponsor:
Information provided by (Responsible Party):
Juan F. Masa, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier:
NCT01405976
First received: July 3, 2008
Last updated: December 12, 2012
Last verified: December 2012

July 3, 2008
December 12, 2012
November 2009
November 2013   (final data collection date for primary outcome measure)
Days of hospitalization [ Time Frame: at the end of two months and three years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01405976 on ClinicalTrials.gov Archive Site
Number of Dropouts for Medical reasons and mortality [ Time Frame: two months, three years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Alternative of Treatment in Obesity Hypoventilation Syndrome
Mid-and Long-term Efficacy of Ventilation Non-invasive and Continuos Positive Airway Pressure in Obesity Hipoventilation Syndrome

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity Hypoventilation Syndrome
Device: diet, oxygen, noninvasive ventilation, CPAP
diet, oxygen, noninvasive ventilation, CPAP
  • Active Comparator: 1
    Intervention: Device: diet, oxygen, noninvasive ventilation, CPAP
  • Active Comparator: 2
    Intervention: Device: diet, oxygen, noninvasive ventilation, CPAP
  • Active Comparator: 3
    Intervention: Device: diet, oxygen, noninvasive ventilation, CPAP
  • Active Comparator: 4
    Intervention: Device: diet, oxygen, noninvasive ventilation, CPAP
  • Active Comparator: 5
    Intervention: Device: diet, oxygen, noninvasive ventilation, CPAP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
440
January 2014
November 2013   (final data collection date for primary outcome measure)

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.
Both
15 Years to 80 Years
No
Contact: Juan F Masa, MD 34-927-256289 fmasa@separ.es
Spain
 
NCT01405976
PI080346
Yes
Juan F. Masa, Sociedad Española de Neumología y Cirugía Torácica
Sociedad Española de Neumología y Cirugía Torácica
Not Provided
Principal Investigator: Juan F Masa, MD Hospital San Pedro de Alcántara. Cáceres. Spain
Sociedad Española de Neumología y Cirugía Torácica
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP