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

NCT01424592 | Unknown

• 1 other identifier: CCHHS IRB 11-027
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Portable sleep apnea testing; Positive airway pressure therapy; Polysomnography

Study Arms (1)

Study Group

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

Device: Testing with a portable sleep apnea monitor .

Interventions

Testing with a portable sleep apnea monitor . DEVICE

Portable sleep apnea testing will performed on referred patients.

Also known as: Alice PDx portable sleep testing system (Philips Respironics, Murraysville, PA)

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- Hospitalized inpatients referred for evaluation of suspected obstructive sleep apnea

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cook County Health: lead

Study Sites (1)

John H Stroger Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Related 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.0168073. eCollection 2016.

  PMID: 27992566 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Swamy Nagubadi, MD

  Attending Physician, Pulmonary, Critical Care and Sleep Medicine

  PRINCIPAL INVESTIGATOR

• Aiman Tulaimat, MD

  Attending Physician, Pulmonary, Critical Care and Sleep Medicine

  STUDY CHAIR

• Rohit Mehta, MD

  Fellow Physician, Pulmonary, Critical Care and Sleep Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician: Pulmonary, Critical Care, and Sleep Medicine

Study Record Dates

• First Submitted: August 25, 2011
• First Posted: August 29, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2024
• Last Updated: April 30, 2019

Record last verified: 2019-04

Locations

US (1)