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Sponsors and Collaborators: |
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Spanish Respiratory Society |
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Information provided by: | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
ClinicalTrials.gov Identifier: | NCT00938977 |
Main objective:
To describe clinical and functional characteristics of the obese hypoventilating patient; to study the relation between the obesity-hypoventilation syndrome (OHS) and the obstructive sleep apnea hypopnea syndrome (OSAHS). In the second stage of the study, to assess patient response to non-invasive mechanical ventilation (NIV) and continuous positive airway pressure (CPAP), and to identify predictors of unfavourable response to treatment.
Methodology:
Expected Results:
Patients with OHS may be characterized and differentiated from obese patients without associated respiratory pathology on the basis of clinical, functional and metabolic data. There is a group of patients with association between OSAHS and OHS that do not respond to treatment with CPAP, and this unfavorable response can be predicted in advance.
Condition | Intervention |
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Obesity Hypoventilation Syndrome |
Device: CPAP Device: Bilevel Support Ventilation (Non-Invasive Ventilation) |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | The Obesity-Hypoventilation Syndrome: A Study Of Clinical Characteristics And Predictive Factors Of Response To Treatment With Continuous Positive Airway Pressure (CPAP) And Non-Invasive Ventilation (NIV) |
Enrollment: | 110 |
Study Start Date: | June 2003 |
Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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CPAP: Active Comparator
Response to treatment before/after treatment in patients with OSAS and SOH
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Device: CPAP
Before and after effect of treatment with CPAP
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Bilevel support ventilation: Active Comparator
Before and after effect of Bilevel support ventilation in patients with SOH without OSA
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Device: Bilevel Support Ventilation (Non-Invasive Ventilation)
before/after effect of Bilevel support ventilation
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Spain | |
Hospital de la Santa Creu i Sant Pau | |
BArcelona, Spain, 08025 |
Principal Investigator: | Neus Salord, MD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Study Chair: | Mercedes Mayos, MD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Responsible Party: | Hospital de la Santa Creu i Sant Pau ( Neus Salord Oleo ) |
Study ID Numbers: | HospitalSCSP |
Study First Received: | July 13, 2009 |
Last Updated: | July 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00938977 History of Changes |
Health Authority: | Spain: Ethics Committee |
Obesity Hypoventilation syndrome cytokines Adipokines |
continuous positive airway pressure bilevel support ventilation Response to continuous positive airway pressure |
Obesity Sleep Apnea Syndromes Apnea Obesity Hypoventilation Syndrome Sleep Apnea, Obstructive Respiration Disorders Hypoventilation Dyssomnias Sleep Disorders |
Overweight Sleep Disorders, Intrinsic Body Weight Signs and Symptoms Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms, Respiratory Nutrition Disorders Overnutrition |
Obesity Sleep Apnea Syndromes Disease Apnea Nervous System Diseases Obesity Hypoventilation Syndrome Sleep Apnea, Obstructive Respiration Disorders Hypoventilation Sleep Disorders Dyssomnias |
Overweight Sleep Disorders, Intrinsic Body Weight Signs and Symptoms Pathologic Processes Respiratory Insufficiency Respiratory Tract Diseases Syndrome Signs and Symptoms, Respiratory Nutrition Disorders Overnutrition |