Comparison of In-lab PSG to WP200 for Assessing Sleep Parameters

Sleep Clinical Trial

Official title:

Testing for Sleep Apnea in Adolescence Subjects With the WP200/WP200U Compared to an In-lab Overnight PSG Testing

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02378831
• Other study ID #: WP200/U-adolescence- 001
• Status: Withdrawn
• Phase: N/A
• First received: February 17, 2015
• Last updated: August 25, 2015
• Start date: March 2016

Study information

• Verified date: February 2015
• Source: Itamar-Medical, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIsrael: Ministry of HealthCanada: Health Canada
• Study type: Observational

Clinical Trial Summary

The WP200 and/or WP200U will be compared with a PSG system which is a digital physiological recorder system, cleared for use for clinical sleep studies. The manual scoring of the PSG data, performed by a trained and authorized scorer, according to the AASM (American Academy of Sleep Medicine) guidelines, serves as a "gold standard" for all determinations of efficacy.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• Age between 12-17

• Subjects with a legal guardian that is able to read understand and sign the informed consent form

• Willing to sleep with the WP200/WP200U and PSG simultaneously in the sleep lab

Exclusion Criteria:

• Permanent pacemaker: atrial pacing or VVI without sinus rhythm.

• Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sleep

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Itamar-Medical, Israel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity, specificity, obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the "gold standard"		1 night	No
Primary	correlation obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the "gold standard"		1 night	No
Primary	Agreement obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the "gold standard"		1 night	No