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

April 26, 2019 updated by: Swamy Nagubadi, John H. Stroger Hospital

Inpatient Portable Sleep Apnea Testing of Hospitalized Medical Patients for the Evaluation of Obstructive Sleep Apnea Prospectively Compared to Outpatient Laboratory-based Polysomnography

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • John H Stroger Hospital of Cook County

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the hospital under the general medicine service referred for evaluation of suspected obstructive sleep apnea.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Group
Hospitalized inpatients referred by a general medicine service for evaluation of obstructive sleep apnea.
Device: Testing with a portable sleep apnea monitor .
Portable sleep apnea testing will performed on referred patients.
Other Names:
  • Alice PDx portable sleep testing system (Philips Respironics, Murraysville, PA)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

John H. Stroger Hospital

Investigators

  • Principal Investigator: Swamy Nagubadi, MD, Attending Physician, Pulmonary, Critical Care and Sleep Medicine
  • Study Chair: Aiman Tulaimat, MD, Attending Physician, Pulmonary, Critical Care and Sleep Medicine
  • Study Director: Rohit Mehta, MD, Fellow Physician, Pulmonary, Critical Care and Sleep Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ANTICIPATED)

June 1, 2022

Study Completion (ANTICIPATED)

December 1, 2024

Study Registration Dates

First Submitted

August 25, 2011

First Submitted That Met QC Criteria

August 25, 2011

First Posted (ESTIMATE)

August 29, 2011

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2019

Last Update Submitted That Met QC Criteria

April 26, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCHHS IRB 11-027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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