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Alternative of Treatment in Obesity Hypoventilation Syndrome

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ClinicalTrials.gov Identifier: NCT01405976
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):

July 3, 2008
July 29, 2011
September 25, 2017
May 2009
May 2013   (Final data collection date for primary outcome measure)
  • Days of hospitalization [ Time Frame: at least three years ]
    Days of hospitalization
  • PaCO2 [ Time Frame: at the end of first two months ]
    PaCO2
Days of hospitalization [ Time Frame: at the end of two months and three years ]
Complete list of historical versions of study NCT01405976 on ClinicalTrials.gov Archive Site
  • Number of Dropouts for Medical reasons and mortality [ Time Frame: at least three years ]
    Number of Dropouts for Medical reasons and mortality
  • quality of life [ Time Frame: two months and three years ]
    quality of life
  • respiratory function [ Time Frame: two months and three years ]
    respiratory function
  • polysomnographic parameters [ Time Frame: two months ]
    polysomnographic parameters
  • molecular inflammation and endothelial dysfunction [ Time Frame: two months and three years ]
    molecular inflammation and endothelial dysfunction
  • echocardiographic parameters [ Time Frame: two months and three years ]
    echocardiographic parameters
  • Blood pressure and new cardiovascular events [ Time Frame: three years ]
    Blood pressure and new cardiovascular events
Number of Dropouts for Medical reasons and mortality [ Time Frame: two months, three years ]
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 Hypoventilation Syndrome
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Obesity Hypoventilation Syndrome
Device: life style modification, noninvasive ventilation, CPAP
life style modification, noninvasive ventilation, CPAP
  • Active Comparator: 1
    NIV for severe OSA group
    Intervention: Device: life style modification, noninvasive ventilation, CPAP
  • Active Comparator: 2
    CPAP for severe OSA group
    Intervention: Device: life style modification, noninvasive ventilation, CPAP
  • Active Comparator: 3
    Life stile modification for severe OSA group
    Intervention: Device: life style modification, noninvasive ventilation, CPAP
  • Active Comparator: 4
    NIV for non-severe OSA group
    Intervention: Device: life style modification, noninvasive ventilation, CPAP
  • Active Comparator: 5
    Life stile modification for non-severe OSA group
    Intervention: Device: life style modification, noninvasive ventilation, CPAP

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
440
July 2017
May 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.
Sexes Eligible for Study: All
15 Years to 80 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01405976
PI080346
Yes
Not Provided
Plan to Share IPD: No
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
January 2017

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