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

NCT00942669 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2012-06-07

No results posted yet for this study

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.

Conditions

  • Sleep Apnea Syndrome

Interventions

DEVICE

SleepStrip OTC(TM)

self contained SAS screening device

Sponsors & Collaborators

  • Scientific Laboratory Products, Ltd.

    lead INDUSTRY

Principal Investigators

  • Giora Pillar, Prof. · Technion Sleep Disorders Center, Rambam Medical Centaer, Israel

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-11-30
Completion
2012-02-29

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00942669 on ClinicalTrials.gov