Status:
COMPLETED
Alternative of Treatment in Obesity Hypoventilation Syndrome
Lead Sponsor:
Sociedad Española de Neumología y Cirugía Torácica
Conditions:
Obesity Hypoventilation Syndrome
Eligibility:
All Genders
15-80 years
Phase:
NA
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 ...
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 rand...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT01405976
Start Date
May 1 2009
End Date
July 1 2017
Last Update
September 25 2017
Active Locations (1)
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1
Hospital San Pedro de Alcántara. Servicio Extremeño de Salud
Cáceres, Spain, 10003