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Obesity Hypoventilation Syndrome Prevalence Study

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ClinicalTrials.gov Identifier: NCT01964339
Recruitment Status : Terminated (This study was stopped due to low recruitment.)
First Posted : October 17, 2013
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Philips Respironics

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

Condition or disease Intervention/treatment
Obesity Hypoventilation Syndrome 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.

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Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Obesity Hypoventilation Syndrome Prevalence Study
Actual Study Start Date : October 9, 2013
Actual Primary Completion Date : May 21, 2014
Actual Study Completion Date : May 21, 2014

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




Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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).

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

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): NCT01964339


Locations
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United States, Louisiana
Ochsner Baptist Medical Center
New Orleans, Louisiana, United States, 70115
Sponsors and Collaborators
Philips Respironics
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Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT01964339    
Other Study ID Numbers: HRC-1240-OHSPREV-MS
First Posted: October 17, 2013    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Additional relevant MeSH terms:
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Hypoventilation
Obesity Hypoventilation Syndrome
Obesity
Syndrome
Disease
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases