The Obesity-hypoventilation Syndrome Study of Clinical Characteristics and Predictive Factors of Response to Treatment

NCT00938977 | Completed

• 1 other identifier: HospitalSCSP
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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. 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.

Conditions

Obesity Hypoventilation Syndrome

Keywords

Obesity Hypoventilation syndrome; cytokines; Adipokines; continuous positive airway pressure; bilevel support ventilation; Response to continuous positive airway pressure

Study Arms (2)

CPAP

ACTIVE COMPARATOR

Response to treatment before/after treatment in patients with OSAS and SOH

Device: 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)

Interventions

CPAP DEVICE

Before and after effect of treatment with CPAP

CPAP

Bilevel Support Ventilation (Non-Invasive Ventilation) DEVICE

before/after effect of Bilevel support ventilation

Bilevel support ventilation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obesity degree I-III (Body mass index, BMI \>30 Kg/m2)
• Stable daytime PCO2 \>45 mmHg.
• Age \< 75 years
• Absence of other parenchymal, respiratory or neuromuscular diseases, diseases of the chest wall which may occur concomitantly with hypoventilation.

You may not qualify if:

• Cognitive disorders that interfere with the administration of the clinical questionnaires.
• Severe comorbidity.
• FEV1/FVC ratio \< 65% in the forced spirometry.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Spanish Respiratory Society: collaborator

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Related Publications (1)

• Salord N, Mayos M, Miralda RM, Farre A, Carreras M, Sust R, Masuet-Aumatell C, Rodriguez J, Perez A. Continuous positive airway pressure in clinically stable patients with mild-to-moderate obesity hypoventilation syndrome and obstructive sleep apnoea. Respirology. 2013 Oct;18(7):1135-42. doi: 10.1111/resp.12131.

  PMID: 23714281 DERIVED

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Neus Salord, MD

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

• Mercedes Mayos, MD

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 13, 2009
• First Posted: July 14, 2009
• Study Start: June 1, 2003
• Primary Completion: June 1, 2006
• Last Updated: July 14, 2009

Record last verified: 2009-07

Locations

ES (1)