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.

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00942669

Enrollment

Registered

2009-07-21

Start date

2009-08-31

Completion date

2012-02-29

Last updated

2012-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea Syndrome

Keywords

Sleep Apnea Syndrome, SAS, SleepStrip OTC

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.

Interventions

DEVICESleepStrip OTC(TM)

self contained SAS screening device

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026