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

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ClinicalTrials.gov Identifier: NCT01424592
Recruitment Status : Unknown
Verified August 2015 by Swamy Nagubadi, John H. Stroger Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 29, 2011
Last Update Posted : September 1, 2015
Sponsor:
Information provided by (Responsible Party):
Swamy Nagubadi, John H. Stroger Hospital

Brief 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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Device: Testing with a portable sleep apnea monitor .

Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Inpatient Portable Sleep Apnea Testing of Hospitalized Medical Patients for the Evaluation of Obstructive Sleep Apnea Prospectively Compared to Outpatient Laboratory-based Polysomnography
Study Start Date : April 2011
Actual Primary Completion Date : February 2015
Estimated Study Completion Date : March 2016

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U.S. FDA Resources

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




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01424592


Locations
United States, Illinois
John H Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
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

Responsible Party: Swamy Nagubadi, Attending Physician: Pulmonary, Critical Care, and Sleep Medicine, John H. Stroger Hospital
ClinicalTrials.gov Identifier: NCT01424592     History of Changes
Other Study ID Numbers: CCHHS IRB 11-027
First Posted: August 29, 2011    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015

Keywords provided by Swamy Nagubadi, John H. Stroger Hospital:
Portable sleep apnea testing
Positive airway pressure therapy
Polysomnography

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Nervous System Diseases