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

June 6, 2012 updated by: Scientific Laboratory Products, Ltd.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • The Technion Sleep Disorders Center, Rambam Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: SleepStrip OTC(TM)
self contained SAS screening device
Other Names:
  • PSG
  • Sleep Apnea
  • SleepStrip OTC
  • SAS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
The data will be analyzed after conclusion of tests of 200 home studies, no later than June 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scientific Laboratory Products, Ltd.

Investigators

  • Principal Investigator: Giora Pillar, Prof., Technion Sleep Disorders Center, Rambam Medical Centaer, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

July 11, 2009

First Submitted That Met QC Criteria

July 19, 2009

First Posted (Estimate)

July 21, 2009

Study Record Updates

Last Update Posted (Estimate)

June 7, 2012

Last Update Submitted That Met QC Criteria

June 6, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SS-OTC-346 CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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