NCT02053012

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2018

Completed
Last Updated

April 10, 2018

Status Verified

April 1, 2018

Enrollment Period

4.1 years

First QC Date

January 31, 2014

Last Update Submit

April 9, 2018

Conditions

Snoring

Outcome Measures

Primary Outcomes (1)

  • Reaction time

    We plan to measure reaction times via a 10 minute psychomotor vigilance test (PVT, Ambulatory Monitoring Inc., NY) device.

    10 minutes

Study Arms (1)

PVT-192

Device: PVT-192

Interventions

PVT-192DEVICE

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

PVT-192

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children who snore and are coming to Nationwide Children's for a sleep study or adenotonsillectomy.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Snoring

Condition Hierarchy (Ancestors)

Respiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

January 31, 2014

First Posted

February 3, 2014

Study Start

January 1, 2014

Primary Completion

February 23, 2018

Study Completion

February 23, 2018

Last Updated

April 10, 2018

Record last verified: 2018-04

Locations

US(1)