Obesity Hypoventilation Syndrome Prevalence Study

Terminated

• Conditions: Obesity Hypoventilation Syndrome
• Interventions: Other: BMI greater than or equal to 30kg/m2 scheduled for PSG. Undergo blood draw (venous blood gas and metabolic panel) and data collection from PSG study.; Other: BMI greater than or equal to 30kg/m2 scheduled for PSG. Undergo blood draw (arterial blood gas and metabolic panel) and data collection from PSG study.

• Registration Number: NCT01964339
• Lead Sponsor: Philips Respironics

Brief Summary

This is an observational study to characterize the prevalence of Obesity Hypoventilation Syndrome in patients referred to the sleep lab.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-09
• Study First Submitted: 2013-10-14
• Study First Submitted QC: 2013-10-14
• Study First Posted: 2013-10-17
• Primary Completion: 2014-05-21
• Study Completion: 2014-05-21
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-07
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Greater than or equal to 21 yrs. of age
• Referred to sleep lab for diagnostic PSG, initial titration PSG or split night PSG as routine clinical care
• BMI greater than or equal to 30kg/m2

Exclusion Criteria

• Acutely ill or medically unstable to participate per PI
• Current positive airway pressure(PAP therapy)users
• Medical History of Chronic Obstructive Pulmonary Disease(COPD)
• Incapable of providing own informed consent
• BMI less than 30kg/m2

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BMI greater than or equal to 30kg/m2 -venous	BMI greater than or equal to 30kg/m2 scheduled for PSG. Undergo blood draw (venous blood gas and metabolic panel) and data collection from PSG study.	BMI greater than or equal to 30kg/m2 scheduled for PSG as part of routine clinical care. Participants will undergo blood draw (venous blood gas and metabolic panel) and data collection from PSG study.
BMI greater than or equal to 30kg/m2 - arterial	BMI greater than or equal to 30kg/m2 scheduled for PSG. Undergo blood draw (arterial blood gas and metabolic panel) and data collection from PSG study.	BMI greater than or equal to 30kg/m2 scheduled for PSG as part of routine clinical care. Participants will undergo blood draw (arterial blood gas and metabolic panel) and data collection from PSG study.

Primary Outcome Measures

Name	Time	Method
Baseline venous blood draw	single blood draw	The study involves a venipuncture and data collection at the time of sleep study. Data collection will be correlated to blood draw results.

Trial Locations

Locations (1)

Ochsner Baptist Medical Center; 🇺🇸 New Orleans, Louisiana, United States