Obesity Hypoventilation Syndrome Prevalence Study

Obesity Hypoventilation Syndrome Clinical Trial

Official title:

Obesity Hypoventilation Syndrome Prevalence Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01964339
• Other study ID #: HRC-1240-OHSPREV-MS
• Status: Terminated
• Start date: October 9, 2013
• Est. completion date: May 21, 2014

Study information

• Verified date: December 2018
• Source: Philips Respironics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: May 21, 2014
• Est. primary completion date: May 21, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoventilation
• Obesity
• Obesity Hypoventilation Syndrome
• Syndrome

Intervention

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.
Venous blood gas, basic metabolic panel, PSG variable data collection.
• 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.
Arterial blood gas, basic metabolic panel, PSG variable data collection

Locations

Country	Name	City	State
United States	Ochsner Baptist Medical Center	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Philips Respironics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Standard polysomnography (PSG) variables	Standard PSG variables will be collected post PSG study. Standard variables include total sleep time, sleep efficiency, hypopneas, apneas (obstructive, central, mixed), stages of sleep, oxygen desaturation (minimum and averages during sleep).	once
Other	Key demographic characteristics will be collected.	Key demographics will be collected including gender, age, height, and weight. Hip, waist and neck measurements will be collected.	once
Primary	Baseline venous 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.	single blood draw