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| Sponsor: | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
|---|---|
| Collaborator: |
Spanish Respiratory Society |
| Information provided by: | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| ClinicalTrials.gov Identifier: | NCT00938977 |
Purpose
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:
In the second stage patients with OHS will be divided into two subgroups: group 1: patients with polysomnography (PSG) suggestive of hypoventilation, in whom NIV treatment will be initiated; group 2: patients with PSG suggestive of OSAHS (apnea-hypopnea index >15), who will be administered CPAP. Patients will be examined one month and three months after the start of treatment. The same measurements will be carried out as at the beginning of the study, with the exception of the polysomnographic study. Nonetheless, pulse oximetry and arterial gases will be performed on waking.
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 |
|---|---|
|
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 |
|---|---|
|
CPAP: Active Comparator
Response to treatment before/after treatment in patients with OSAS and SOH
|
Device: CPAP
Before and after effect of treatment with CPAP
|
|
Bilevel support ventilation: Active Comparator
Before and after effect of Bilevel support ventilation in patients with SOH without OSA
|
Device: Bilevel Support Ventilation (Non-Invasive Ventilation)
before/after effect of Bilevel support ventilation
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| 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 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 |