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

NCT ID: NCT00942669

Last Updated: 2012-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2012-02-29

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.

Conditions

Sleep Apnea Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SleepStrip OTC(TM)

Intervention Type: DEVICE

self contained SAS screening device

Interventions

SleepStrip OTC(TM)

self contained SAS screening device

Intervention Type: DEVICE

Other Intervention Names

SleepStrip OTC; SAS; Sleep Apnea; PSG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scientific Laboratory Products, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giora Pillar, Prof.

Role: PRINCIPAL_INVESTIGATOR

Technion Sleep Disorders Center, Rambam Medical Centaer, Israel

Locations

The Technion Sleep Disorders Center, Rambam Medical Center

Haifa, , Israel

Countries

Israel

Other Identifiers

SS-OTC-346 CTIL

Identifier Type: -

Identifier Source: org_study_id