Comparing the Sleep Strip OTC™ Accuracy in Screening for Sleep Apnea Syndrome Against the Reference Method, an In-lab Full Night Polysomnographic (PSG)
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.
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2009
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2009
CompletedFirst Posted
Study publicly available on registry
July 21, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedJune 7, 2012
June 1, 2012
2.3 years
July 11, 2009
June 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Paired T-test or signed-rank test; McNemar's test; Sensitivity Analyses
The data will be analyzed after conclusion of tests of 200 home studies, no later than June 2010
Study Arms (1)
SleepStrip OTC(TM)
EXPERIMENTALParticipants 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.
Interventions
self contained SAS screening device
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Technion Sleep Disorders Center, Rambam Medical Center
Haifa, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giora Pillar, Prof.
Technion Sleep Disorders Center, Rambam Medical Centaer, Israel
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2009
First Posted
July 21, 2009
Study Start
August 1, 2009
Primary Completion
November 1, 2011
Study Completion
February 1, 2012
Last Updated
June 7, 2012
Record last verified: 2012-06