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NCT02053012 Clinical Trial

Investigating Reaction Time Among Children Who Snore

Snoring Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02053012
Other study ID # IRB14-00003
Secondary ID
Status Completed
Phase
First received January 31, 2014
Last updated April 9, 2018
Start date January 2014
Est. completion date February 23, 2018

Study information
Verified date April 2018
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators feel that children who have OSA or sleep-disordered breathing may have a different reaction time than normal variants. Children who have OSA are known to have behavioral and sleep patterns that are different. It makes sense their reaction time may be different than normal as well. We plan to measure reaction times via a 10 minute psychomotor vigilance test device in children who snore who are coming in for a sleep study or for adenotonsillectomy.

Recruitment information / eligibility
Status Completed
Enrollment 93
Est. completion date February 23, 2018
Est. primary completion date February 23, 2018
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria:

- Ability to understand how to perform reaction time test and complete without assistance.

Exclusion Criteria:

- Children who are unable to understand or perform test or parents refusal.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• PVT-192
PVT-192 Psychomotor Vigilance Task Monitor is a hand-held, self-contained system used for repetitive reaction time measurement.

Locations
Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Vidya Raman

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reaction time We plan to measure reaction times via a 10 minute psychomotor vigilance test (PVT, Ambulatory Monitoring Inc., NY) device. 10 minutes
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