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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity Hypoventilation Syndrome | Device: life style modification, noninvasive ventilation, CPAP | Not Applicable |
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 |
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
|
- Days of hospitalization [ Time Frame: at least three years ]Days of hospitalization
- PaCO2 [ Time Frame: at the end of first two months ]PaCO2
- 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

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Ages Eligible for Study: | 15 Years to 80 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Spain | |
Hospital San Pedro de Alcántara. Servicio Extremeño de Salud | |
Cáceres, Spain, 10003 |
Principal Investigator: | Juan F Masa, MD | Hospital San Pedro de Alcántara. Cáceres. Spain |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
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:
Syndrome Obesity Hypoventilation Obesity Hypoventilation 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 |