NCT01964339

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2013

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2014

Completed
Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

7 months

First QC Date

October 14, 2013

Last Update Submit

December 7, 2018

Conditions

Obesity Hypoventilation Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

Other Outcomes (2)

  • Standard polysomnography (PSG) variables

    once

  • Key demographic characteristics will be collected.

    once

Study Arms (2)

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.

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.

Interventions

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

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

BMI greater than or equal to 30kg/m2 -venous
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.OTHER

Arterial blood gas, basic metabolic panel, PSG variable data collection

BMI greater than or equal to 30kg/m2 - arterial

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ochsner Baptist Medical Center

New Orleans, Louisiana, 70115, United States

Location

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome

Interventions

Blood Gas Analysis

Condition Hierarchy (Ancestors)

Sleep Apnea, ObstructiveSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesHypoventilationRespiratory InsufficiencySleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2013

First Posted

October 17, 2013

Study Start

October 9, 2013

Primary Completion

May 21, 2014

Study Completion

May 21, 2014

Last Updated

December 11, 2018

Record last verified: 2018-12

Locations

US(1)