Status:
ACTIVE_NOT_RECRUITING
Overnight Polysomnography and Respiratory Volume Monitor
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
Respiratory Motion, Inc.
Conditions:
Obstructive Sleep Apnea (OSA)
Eligibility:
All Genders
18+ years
Brief Summary
Sleep disordered breathing; specifically obstructive sleep apnea (OSA) is a disease affecting 8-12% of the general population and often more than 70% of the bariatric surgical population. OSA is chara...
Detailed Description
This is an observational pilot study to evaluate the clinical applicability of the ExSpiron Respiratory Volume Monitor (RVM) in patients with suspected sleep apnea. Previous work has demonstrated the ...
Eligibility Criteria
Inclusion
- Adult Patients referred to the sleep lab for a polysomnography for suspicion of sleep disordered breathing aged ≥ 18 years. Ability to provide written informed consent.
Exclusion
- \- Patients not competent to give informed consent, patients with implantable electronic devices, such as pacemakers, stimulators, etc. pregnant or lactating women.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02295306
Start Date
June 1 2013
End Date
July 31 2026
Last Update
February 28 2025
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111