- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02053012
Investigating Reaction Time Among Children Who Snore
April 9, 2018 updated by: Vidya Raman
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
93
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ohio
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children who snore and are coming to Nationwide Children's for a sleep study or adenotonsillectomy.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PVT-192
|
PVT-192 Psychomotor Vigilance Task Monitor is a hand-held, self-contained system used for repetitive reaction time measurement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reaction time
Time Frame: 10 minutes
|
We plan to measure reaction times via a 10 minute psychomotor vigilance test (PVT, Ambulatory Monitoring Inc., NY) device.
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
February 23, 2018
Study Completion (Actual)
February 23, 2018
Study Registration Dates
First Submitted
January 31, 2014
First Submitted That Met QC Criteria
January 31, 2014
First Posted (Estimate)
February 3, 2014
Study Record Updates
Last Update Posted (Actual)
April 10, 2018
Last Update Submitted That Met QC Criteria
April 9, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB14-00003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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