Comparing the Sleep Strip OTC™ Accuracy in Screening for Sleep Apnea Syndrome Against the Reference Method, an In-lab Full Night Polysomnographic (PSG)
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|ClinicalTrials.gov Identifier: NCT00942669|
Recruitment Status : Completed
First Posted : July 21, 2009
Last Update Posted : June 7, 2012
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea Syndrome||Device: SleepStrip OTC(TM)||Phase 1 Phase 2|
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, attended Polysomnographic (PSG) Study.
The study will consist of two phases:
I: Optimization Phase:will be performed at the Clinic; 20 participants will be enrolled. Each participant will be connected simultaneously to the SleepStrip OTC(TM) and to the standard lab sensors and recorder. This phase is intended to allow SLP to optimize the analysis parameters for optimal performance and will be considered as a pilot phase.
II: Equivalence phase: At least 180 participants will be enrolled. All participants will receive the SleepStrip OTC(TM) for a night test at home, before or after undergoing an independent PSG test at the Sleep lab. Out of 180 participants, at least 26 participants will receive two SleepStrip OTC(TM) devices for two consecutive night tests at home. The remaining participants will receive one SleepStrip OTC(TM) for one night test.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Single Center, Open, Equivalence, Two Phase Study Comparing the Sleep Strip OTC™ Accuracy in Screening for Sleep Apnea Syndrome Against the Reference Method, an In-lab Full Night Polysomnographic (PSG) Study.|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||February 2012|
Experimental: SleepStrip OTC(TM)
Participants will receive the SleepStrip OTC(TM) for a night (or two) test at home, before or after undergoing an independent PSG test at the Sleep lab. The reading of both methods will be analyzed.
Device: SleepStrip OTC(TM)
self contained SAS screening device
- Paired T-test or signed-rank test; McNemar's test; Sensitivity Analyses [ Time Frame: The data will be analyzed after conclusion of tests of 200 home studies, no later than June 2010 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942669
|The Technion Sleep Disorders Center, Rambam Medical Center|
|Principal Investigator:||Giora Pillar, Prof.||Technion Sleep Disorders Center, Rambam Medical Centaer, Israel|