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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Scientific Laboratory Products, Ltd.
ClinicalTrials.gov Identifier:
NCT00942669
First received: July 11, 2009
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Sleep Apnea Syndrome
 Device: SleepStrip OTC(TM)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Scientific Laboratory Products, Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: August 2009
Study Completion Date: February 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • SleepStrip OTC
  • SAS
  • Sleep Apnea
  • PSG

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942669

Locations
Israel
The Technion Sleep Disorders Center, Rambam Medical Center
Haifa, Israel
Sponsors and Collaborators
Scientific Laboratory Products, Ltd.
Investigators
Principal Investigator: Giora Pillar, Prof. Technion Sleep Disorders Center, Rambam Medical Centaer, Israel
  More Information

No publications provided

Responsible Party: Scientific Laboratory Products, Ltd.
ClinicalTrials.gov Identifier: NCT00942669     History of Changes
Other Study ID Numbers: SS-OTC-346 CTIL
Study First Received: July 11, 2009
Last Updated: June 6, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Scientific Laboratory Products, Ltd.:
Sleep Apnea Syndrome
SAS
SleepStrip OTC

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2013