Status:
COMPLETED
A Multi-Center Study to Assess the Performance of Saturation Patterns.
Lead Sponsor:
Medtronic - MITG
Conditions:
Sleep-Disordered Breathing
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Brief Summary
A multi-center, prospective, single-visit study designed to acquire physiologic pulse oximeter waveform data during standard polysomnography (PSG) studies performed at multiple different Sleep Lab Cen...
Detailed Description
The polysomnograms are clinically indicated studies in patients suspected of having sleep-disordered breathing, including, but not limited to: obstructive sleep apnea, complex sleep apnea and/or centr...
Eligibility Criteria
Inclusion
- Subjects will be referred to the Sleep Lab Center for evaluation of possible sleep-disordered breathing.
- Polysomnography (PSG) is obtained as part of normal, standard clinical practice.
- Subject is able to and willingly signs the informed consent form.
Exclusion
- Subject and/or parent/legal guardian is, in the opinion of the investigator, mentally and/or physically unable to provide informed consent/child assent and/or to complete all requirements of the protocol.
- Subject is currently participating in or has participated in an investigational drug study within seven (7) days of enrollment.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00775346
Start Date
August 1 2008
End Date
October 1 2008
Last Update
August 7 2014
Active Locations (3)
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1
SleepFit
Broomfield, Colorado, United States, 80023
2
Clayton Sleep Institute
Maplewood, Missouri, United States, 63143
3
Sleep Medicine Centers
West Seneca, New York, United States, 14224