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Obesity Hypoventilation Syndrome Prevalence Study

Obesity Hypoventilation Syndrome Prevalence Study

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01964339
Enrollment
44
Registered
2013-10-17
Start date
2013-10-09
Completion date
2014-05-21
Last updated
2018-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Hypoventilation Syndrome

Brief summary

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

Interventions

OTHERBMI 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.

OTHERBMI 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

Sponsors

Philips Respironics
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Baseline venous blood drawsingle blood drawThe study involves a venipuncture and data collection at the time of sleep study. Data collection will be correlated to blood draw results.

Other

MeasureTime frameDescription
Standard polysomnography (PSG) variablesonceStandard 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).
Key demographic characteristics will be collected.onceKey demographics will be collected including gender, age, height, and weight. Hip, waist and neck measurements will be collected.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026