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.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Paired T-test or signed-rank test; McNemar's test; Sensitivity Analyses
Study Overview
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, 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
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.
Intervention: SleepStrip OTC(TM) (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported