Alternative of Treatment in Obesity Hypoventilation Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
Obesity Hypoventilation Syndrome
Device: diet, oxygen, noninvasive ventilation, CPAP
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mid-and Long-term Efficacy of Ventilation Non-invasive and Continuos Positive Airway Pressure in Obesity Hipoventilation Syndrome

Resource links provided by NLM:


Further study details as provided by Sociedad Española de Neumología y Cirugía Torácica:

Primary Outcome Measures:
  • Days of hospitalization [ Time Frame: at the end of two months and three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Dropouts for Medical reasons and mortality [ Time Frame: two months, three years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 440
Study Start Date: November 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Device: diet, oxygen, noninvasive ventilation, CPAP
diet, oxygen, noninvasive ventilation, CPAP
Active Comparator: 2 Device: diet, oxygen, noninvasive ventilation, CPAP
diet, oxygen, noninvasive ventilation, CPAP
Active Comparator: 3 Device: diet, oxygen, noninvasive ventilation, CPAP
diet, oxygen, noninvasive ventilation, CPAP
Active Comparator: 4 Device: diet, oxygen, noninvasive ventilation, CPAP
diet, oxygen, noninvasive ventilation, CPAP
Active Comparator: 5 Device: diet, oxygen, noninvasive ventilation, CPAP
diet, oxygen, noninvasive ventilation, CPAP

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405976

Contacts
Contact: Juan F Masa, MD 34-927-256289 fmasa@separ.es

Locations
Spain
Hospital San Pedro de Alcántara. Servicio Extremeño de Salud Recruiting
Cáceres, Spain, 10003
Contact: Juan F Masa, MD    34-927-256289    fmasa@separ.es   
Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Investigators
Principal Investigator: Juan F Masa, MD Hospital San Pedro de Alcántara. Cáceres. Spain
  More Information

No publications provided

Responsible Party: Juan F. Masa, MD, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier: NCT01405976     History of Changes
Other Study ID Numbers: PI080346
Study First Received: July 3, 2008
Last Updated: December 12, 2012
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by Sociedad Española de Neumología y Cirugía Torácica:
sleep apneas
noninvasive ventilation
CPAP

Additional relevant MeSH terms:
Obesity
Syndrome
Hypoventilation
Respiratory Insufficiency
Obesity Hypoventilation Syndrome
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014