Obstructive Sleep ApneaNCT01424592
In-Hospital Portable Sleep Monitoring for the Evaluation of Obstructive Sleep Apnea (OSA)
An observational study of Obstructive Sleep Apnea, run by Cook County Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Testing with a portable sleep apnea monitor .
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the hospital under the general medicine service referred for evaluation of suspected obstructive sleep apnea.
Who may be able to join
- Hospitalized inpatients referred for evaluation of suspected obstructive sleep apnea
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
John H Stroger Hospital of Cook County
Chicago, Illinois, 60612
About this study
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
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
- Being tested
- Testing with a portable sleep apnea monitor .
- Keywords
- Portable sleep apnea testing, Positive airway pressure therapy, Polysomnography
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing with a portable sleep apnea monitor .Device
Also called Alice PDx portable sleep testing system (Philips Respironics, Murraysville, PA)
Portable sleep apnea testing will performed on referred patients.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Hospitalized inpatients referred by a general medicine service for evaluation of obstructive sleep apnea. Receives: Device: Testing with a portable sleep apnea monitor . |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2022 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cook County Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Swamy Nagubadi, Cook County Health
- Investigators
- Swamy Nagubadi, MD, Principal investigator, Attending Physician, Pulmonary, Critical Care and Sleep MedicineAiman Tulaimat, MD, Study chair, Attending Physician, Pulmonary, Critical Care and Sleep MedicineRohit Mehta, MD, Study director, Fellow Physician, Pulmonary, Critical Care and Sleep Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424592
- Sponsor's protocol ID
- CCHHS IRB 11-027
- Status last verified
- Apr 2019
- First submitted
- 25 Aug 2011
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27992566
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01424592
- Acronym / sponsor ID
- CCHHS IRB 11-027
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Portable sleep apnea testing, Positive airway pressure therapy, Polysomnography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Cook County HealthOther government
- Study start
- Apr 2011
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 29 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Device: Testing with a portable sleep apnea monitor .Hospitalized inpatients referred by a general medicine service for evaluation of obstructive sleep apnea. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the hospital under the general medicine service referred for evaluation of suspected obstructive sleep apnea.
Key inclusion criteria (1 listed)
- Hospitalized inpatients referred for evaluation of suspected obstructive sleep apnea
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testing with a portable sleep apnea monitor .Also: Alice PDx portable sleep testing system (Philips Respironics, Murraysville, PA)Portable sleep apnea testing will performed on referred patients. | Device | Study Group |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Results publication: PubMed 27992566Nagubadi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Swamy Nagubadi, MD principal investigator
Attending Physician, Pulmonary, Critical Care and Sleep Medicine
Aiman Tulaimat, MD study chair
Attending Physician, Pulmonary, Critical Care and Sleep Medicine
Rohit Mehta, MD study director
Fellow Physician, Pulmonary, Critical Care and Sleep Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Cook County Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01424592, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.