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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by John H. Stroger Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Swamy Nagubadi, John H. Stroger Hospital
ClinicalTrials.gov Identifier:
NCT01424592
First received: August 25, 2011
Last updated: April 24, 2012
Last verified: April 2012
  Purpose

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 Intervention
Obstructive Sleep Apnea
Device: Testing with a portable sleep apnea monitor .

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by John H. Stroger Hospital:

Estimated Enrollment: 140
Study Start Date: April 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: August 25, 2011
Last Updated: April 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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 Disorders
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014