Comparing the Sleep Strip OTC™ Accuracy in Screening for Sleep Apnea Syndrome Against the Reference Method, an In-lab Full Night Polysomnographic (PSG)

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.

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Key information

Conditions

Sleep Apnea Syndrome Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Technion Sleep Disorders Center, Rambam Medical Center

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SleepStrip OTC(TM)

Device

self contained SAS screening device

Other names: SleepStrip OTC, SAS, Sleep Apnea, PSG

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

Sponsors and collaborators

Lead sponsor

Scientific Laboratory Products, Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2012
First posted: Jul 21, 2009
Registry last updated: Jun 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed