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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01424592
Other study ID # CCHHS IRB 11-027
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 2011
Est. completion date December 2024

Study information

Verified date April 2019
Source John H. Stroger Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hypothesis: Portable sleep testing of hospitalized medical inpatients suspected of having OSA is accurate in determining the need for positive airway pressure (PAP) therapy when compared to outpatient laboratory-based polysomnography.

- Hospitalized medical inpatients referred for suspected OSA will be tested with a portable sleep apnea testing device during hospitalization.

- These patients will then undergo an outpatient laboratory-based attended polysomnography after hospital discharge.

- Results of the inpatient portable sleep apnea test will be compared to the outpatient laboratory-based polysomnography in terms of diagnostic accuracy.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 140
Est. completion date December 2024
Est. primary completion date June 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Hospitalized inpatients referred for evaluation of suspected obstructive sleep apnea

Exclusion Criteria:

- Patients admitted to surgical or obstetrics/gynecology services

- Patients with certain medical conditions (altered mental status not related to respiratory failure, septicemia, unstable psychiatric disorder, narcotic abuse and prior diagnosed sleep apnea)

- Patients with certain social histories (prisoners)

- Patients unable to use CPAP (facial deformity and traumatic facial injuries).

Study Design


Intervention

Device:
Testing with a portable sleep apnea monitor .
Portable sleep apnea testing will performed on referred patients.

Locations

Country Name City State
United States John H Stroger Hospital of Cook County Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
John H. Stroger Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Nagubadi S, Mehta R, Abdoh M, Nagori M, Littleton S, Gueret R, Tulaimat A. The Accuracy of Portable Monitoring in Diagnosing Significant Sleep Disordered Breathing in Hospitalized Patients. PLoS One. 2016 Dec 19;11(12):e0168073. doi: 10.1371/journal.pone. — View Citation

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