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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):
Juan F. Masa, Sociedad Española de Neumología y Cirugía Torácica

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Hypoventilation Syndrome Device: life style modification, noninvasive ventilation, CPAP Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Mid-and Long-term Efficacy of Ventilation Non-invasive and Continuos Positive Airway Pressure in Obesity Hypoventilation Syndrome
Actual Study Start Date : May 2009
Actual Primary Completion Date : May 2013
Actual Study Completion Date : July 2017
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
NIV for severe OSA group
 Device: life style modification, noninvasive ventilation, CPAP
life style modification, noninvasive ventilation, CPAP
Active Comparator: 2
CPAP for severe OSA group
 Device: life style modification, noninvasive ventilation, CPAP
life style modification, noninvasive ventilation, CPAP
Active Comparator: 3
Life stile modification for severe OSA group
 Device: life style modification, noninvasive ventilation, CPAP
life style modification, noninvasive ventilation, CPAP
Active Comparator: 4
NIV for non-severe OSA group
 Device: life style modification, noninvasive ventilation, CPAP
life style modification, noninvasive ventilation, CPAP
Active Comparator: 5
Life stile modification for non-severe OSA group
 Device: life style modification, noninvasive ventilation, CPAP
life style modification, noninvasive ventilation, CPAP


Outcome Measures
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Primary Outcome Measures :
  1. Days of hospitalization [ Time Frame: at least three years ]
    Days of hospitalization

  2. PaCO2 [ Time Frame: at the end of first two months ]
    PaCO2


Secondary Outcome Measures :
  1. Number of Dropouts for Medical reasons and mortality [ Time Frame: at least three years ]
    Number of Dropouts for Medical reasons and mortality

  2. quality of life [ Time Frame: two months and three years ]
    quality of life

  3. respiratory function [ Time Frame: two months and three years ]
    respiratory function

  4. polysomnographic parameters [ Time Frame: two months ]
    polysomnographic parameters

  5. molecular inflammation and endothelial dysfunction [ Time Frame: two months and three years ]
    molecular inflammation and endothelial dysfunction

  6. echocardiographic parameters [ Time Frame: two months and three years ]
    echocardiographic parameters

  7. Blood pressure and new cardiovascular events [ Time Frame: three years ]
    Blood pressure and new cardiovascular events


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01405976


Locations
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Spain
Hospital San Pedro de Alcántara. Servicio Extremeño de Salud
Cáceres, Spain, 10003
Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Investigators
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Principal Investigator: Juan F Masa, MD Hospital San Pedro de Alcántara. Cáceres. Spain
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Juan F. Masa, MD, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier: NCT01405976    
Other Study ID Numbers: PI080346
First Posted: July 29, 2011    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Juan F. Masa, Sociedad Española de Neumología y Cirugía Torácica:
sleep apneas
noninvasive ventilation
CPAP
Additional relevant MeSH terms:
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Hypoventilation
Obesity Hypoventilation Syndrome
Obesity
Syndrome
Disease
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
 Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases