The Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea

NCT ID: NCT01276860

Last Updated: 2021-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-09-30

Brief Summary

Obstructive sleep apnea results in decreased attentiveness and response times in patients. The objective of this study is to quantify these consequences in pediatric OSA patients using an already established tool for examining the results of sleep deprivation and fragmentation: psychomotor vigilance testing. PVT has been used in children, but has not been studied in pediatric OSA patients. This study aims to employ PVT along the normal course of diagnosis and treatment of pediatric OSA patients in our clinical practice at Arkansas Children's Hospital. The investigators hypothesize that pediatric OSA patients will exhibit decreased PVT scoring when compared to children without OSA, and that PVT can be used to diagnose and monitor treatment outcomes in these patients.

Conditions

Pediatric Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Psychomotor Vigilance Testing

The purpose of this study is to examine the use of psychomotor vigilance testing (PVT) as a tool in the diagnosis and prediction of pediatric obstructive sleep apnea. PVT simply involves responding to a light by pressing a button on a small handheld device. It is a simple measure of reaction time.

Group Type: OTHER

Psychomotor Vigilance Testing

Intervention Type: DEVICE

The purpose of this study is to examine the use of psychomotor vigilance testing (PVT) as a tool in the diagnosis and prediction of pediatric obstructive sleep apnea. PVT simply involves responding to a light by pressing a button on a small handheld device. It is a simple measure of reaction time.

Interventions

Psychomotor Vigilance Testing

The purpose of this study is to examine the use of psychomotor vigilance testing (PVT) as a tool in the diagnosis and prediction of pediatric obstructive sleep apnea. PVT simply involves responding to a light by pressing a button on a small handheld device. It is a simple measure of reaction time.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Healthy pediatric patients ages 6-18 years old
• with symptoms of OSA (snoring, pauses in sleep breathing, restless sleep, frequent arousals, excellive daytime sleepiness, morning headaches)
• with physical exam findings consistent with adenotonsillar hypertrophy
• those identified as good candidates for adenotonsillectomy
• who are to undergo a polysomnogram as part of their preoperative work-up

Exclusion Criteria

• History of attention deficit disorder, developmental delay, or mental retardation
• Children taking any neurotropic medications (including antiepileptics, antidepressives, and stimulants)
• Children previously treated for OSA (surgically or medically)
• Children with significant comorbidities including other sleep-related disorders

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gresham T Richter, MD

Role: PRINCIPAL_INVESTIGATOR

UAMS, ACH

Locations

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

112316

Identifier Type: -

Identifier Source: org_study_id