The Obesity-hypoventilation Syndrome Study of Clinical Characteristics and Predictive Factors of Response to Treatment
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|ClinicalTrials.gov Identifier: NCT00938977|
Recruitment Status : Completed
First Posted : July 14, 2009
Last Update Posted : July 14, 2009
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.
- Patients: Patients with obesity degree I-III, with pCO2 awake and at rest > 45 mmHg, with no underlying pulmonary or neuromuscular lung disease; two control groups, one of non-hypoventilating obese patients and the other of obese patients with OSAHS, will also be studied over the same period.
- Design: Prospective observational study. In the first stage anthropometric, clinical, functional and metabolic data will be recorded for the obese hypoventilating patients and the two control groups (obese patients without respiratory pathology, and obese patients with OSAHS).
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.
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 or disease||Intervention/treatment||Phase|
|Obesity Hypoventilation Syndrome||Device: CPAP Device: Bilevel Support Ventilation (Non-Invasive Ventilation)||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||June 2006|
Active Comparator: CPAP
Response to treatment before/after treatment in patients with OSAS and SOH
Before and after effect of treatment with CPAP
Active Comparator: Bilevel support ventilation
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
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): NCT00938977
|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|