Obesity Hypoventilation Syndrome Prevalence Study

December 7, 2018 updated by: Philips Respironics
This is an observational study to characterize the prevalence of Obesity Hypoventilation Syndrome in patients referred to the sleep lab.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Ochsner Baptist Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People with a BMI greater than or equal to 30kg/m2 scheduled for a routine polysomnograpy (PSG) test. Participants will be recruited from pulmonology clinics or referred to the sleep lab via hospital admissions.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BMI greater than or equal to 30kg/m2 -venous
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.
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 - arterial
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.
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.
Arterial blood gas, basic metabolic panel, PSG variable data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline venous blood draw
Time Frame: 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.
single blood draw

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standard polysomnography (PSG) variables
Time Frame: once
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
Key demographic characteristics will be collected.
Time Frame: once
Key demographics will be collected including gender, age, height, and weight. Hip, waist and neck measurements will be collected.
once

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Respironics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2013

Primary Completion (Actual)

May 21, 2014

Study Completion (Actual)

May 21, 2014

Study Registration Dates

First Submitted

October 14, 2013

First Submitted That Met QC Criteria

October 14, 2013

First Posted (Estimate)

October 17, 2013

Study Record Updates

Last Update Posted (Actual)

December 11, 2018

Last Update Submitted That Met QC Criteria

December 7, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRC-1240-OHSPREV-MS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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