Comparing the Sleep Strip OTC™ Accuracy in Screening for... | NCT00942669

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Nov 2011Actual

Completion Date

Feb 2012Actual

First Submitted Date

Jul 11, 2009

First Submission Date that Met QC Criteria

Jul 19, 2009

First Posted Date

Jul 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2012

Last Update Posted Date

Jun 7, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SleepStrip OTC(TM)	Experimental	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)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SleepStrip OTC(TM)	Device	self contained SAS screening device	SleepStrip OTC(TM)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Paired T-test or signed-rank test; McNemar's test; Sensitivity Analyses		The data will be analyzed after conclusion of tests of 200 home studies, no later than June 2010

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giora Pillar, Prof.	Technion Sleep Disorders Center, Rambam Medical Centaer, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Technion Sleep Disorders Center, Rambam Medical Center		Haifa			Israel

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases