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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01964339
Other study ID # HRC-1240-OHSPREV-MS
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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