In-Hospital Portable Sleep Monitoring for the Evaluation of Obstructive Sleep Apnea (OSA)

NCT ID: NCT01424592

Last Updated: 2019-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Group

Hospitalized inpatients referred by a general medicine service for evaluation of obstructive sleep apnea.

Testing with a portable sleep apnea monitor .

Intervention Type DEVICE

Portable sleep apnea testing will performed on referred patients.

Interventions

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Testing with a portable sleep apnea monitor .

Portable sleep apnea testing will performed on referred patients.

Intervention Type DEVICE

Other Intervention Names

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Alice PDx portable sleep testing system (Philips Respironics, Murraysville, PA)

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook County Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Swamy Nagubadi

Attending Physician: Pulmonary, Critical Care, and Sleep Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Swamy Nagubadi, MD

Role: PRINCIPAL_INVESTIGATOR

Attending Physician, Pulmonary, Critical Care and Sleep Medicine

Aiman Tulaimat, MD

Role: STUDY_CHAIR

Attending Physician, Pulmonary, Critical Care and Sleep Medicine

Rohit Mehta, MD

Role: STUDY_DIRECTOR

Fellow Physician, Pulmonary, Critical Care and Sleep Medicine

Locations

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John H Stroger Hospital of Cook County

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.0168073. eCollection 2016.

Reference Type RESULT
PMID: 27992566 (View on PubMed)

Other Identifiers

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CCHHS IRB 11-027

Identifier Type: -

Identifier Source: org_study_id

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