Status:
COMPLETED
Comparing the Sleep Strip OTC™ Accuracy in Screening for Sleep Apnea Syndrome Against the Reference Method, an In-lab Full Night Polysomnographic (PSG)
Lead Sponsor:
Scientific Laboratory Products, Ltd.
Conditions:
Sleep Apnea Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The primary purpose of this study is to demonstrate the equivalence of the new Sleep Strip OTC(TM) compared to the reference method of an in-lab, attended full-night polysomnographic (PSG) study.
Detailed Description
A prospective, single center two phase study to evaluate the validity and the predictability of the SleepStrip OTCTM in screening for SAS, as compared to the reference method, an in-lab, full night, a...
Eligibility Criteria
Inclusion
- Male or Female participants, 18 years of age or older at time of enrollment.
- Participants who present at the Technion Sleep Disorder Center for a PSG test, and who are willing comply with study procedures.
- Participants who are willing to sign a Written.
Exclusion
- Participant has a clinically significant untreated chronic disease which may unable him/ her to participate in the study.
- Participant has facial hair or any other skin problem that may hinder proper application of the device on destined facial area.
- Participant is suffering from a respiratory-track infection or a runny nose at enrollment.
- Participant is unable to comprehend the purpose of the study as stated in the participant consent form.
- Participant is unable to comply with the technical requirements of the study.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00942669
Start Date
August 1 2009
End Date
February 1 2012
Last Update
June 7 2012
Active Locations (1)
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1
The Technion Sleep Disorders Center, Rambam Medical Center
Haifa, Israel