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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

July 11, 2009
June 6, 2012
August 2009
November 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00942669 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparing the Sleep Strip OTC™ Accuracy in Screening for Sleep Apnea Syndrome Against the Reference Method, an In-lab Full Night Polysomnographic (PSG)
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Sleep Apnea Syndrome
Device: SleepStrip OTC(TM)
self contained SAS screening device
Other Names:
  • SleepStrip OTC
  • SAS
  • Sleep Apnea
  • PSG
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.
Intervention: Device: SleepStrip OTC(TM)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
February 2012
November 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00942669
SS-OTC-346 CTIL
Yes
Scientific Laboratory Products, Ltd.
Scientific Laboratory Products, Ltd.
Not Provided
Principal Investigator: Giora Pillar, Prof. Technion Sleep Disorders Center, Rambam Medical Centaer, Israel
Scientific Laboratory Products, Ltd.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP