In-Hospital Portable Sleep Monitoring for the Evaluation of Obstructive Sleep Apnea (OSA)
This study is ongoing, but not recruiting participants.
Sponsor:
John H. Stroger Hospital
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
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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
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 Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013