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

NCT01276860 | Completed Results DMC

• 1 other identifier: 112316
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Keywords

Obstructive Sleep Apnea; Pediatric Obstructive Sleep Apnea; OSA; PVT; Psychomotor Vigilance Testing; Psychomotor Vigilance Task

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Achieved Criteria of Obstructive Sleep Apnea in the PVT Assessment

  Subjects with obstructive sleep apnea will be asked to participate in 3 sessions. Your child will be asked to complete some noninvasive tests at each session. These tests consist of Psychomotor Vigilance Task testing. A Psychomotor Vigilance Task (PVT) will measure your level of alertness and attentiveness. The PVT involves pressing a button after hearing a specific tone or seeing a flashing light. This test takes approximately 10 minutes to complete. The PVT testing will be done at the first clinic visit, then before any treatments, and finally after treatments have taken place. Outcome Measure is full completion of the PVT testing.

  10-20 minutes each session, 3 sessions total

Secondary Outcomes (1)

• Number of Participants Who Achieved Criteria of No Sleep Complaints in the PVT Assessment

  10-20 minute session, 1 session

Study Arms (1)

Psychomotor Vigilance Testing

OTHER

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.

Device: Psychomotor Vigilance Testing

Interventions

Psychomotor Vigilance Testing 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.

Psychomotor Vigilance Testing

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead
• Arkansas Children's Hospital Research Institute: collaborator

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Clinical Research Coordinator
• Organization: Arkansas Children's Hospital

boswelljl@archildrens.org

501-364-2018

Study Officials

• Gresham T Richter, MD

  UAMS, ACH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2011
• First Posted: January 13, 2011
• Study Start: May 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 5, 2021
• Results First Posted: June 12, 2020

Record last verified: 2021-05

Locations

US (1)