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

This study has suspended participant recruitment.
(Migration from ARIA to CLARA.)
Sponsor:
Collaborator:
Arkansas Children's Hospital Research Institute
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01276860
First received: January 12, 2011
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Pediatric Obstructive Sleep Apnea
 Device: Psychomotor Vigilance Testing

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • OSA Subject PVT Sessions [ Time Frame: 10-20 minutes each session, 3 sessions total ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Control Subject PVT Session [ Time Frame: 10-20 minute session, 1 session ] [ Designated as safety issue: No ]
    Subjects in the control group without clinical signs and symptoms of sleep apnea will only undergo PVT for one session. Your child will be asked to complete some noninvasive tests at this 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.


Estimated Enrollment: 110
Study Start Date: May 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: 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.
  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276860

Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
University of Arkansas
Arkansas Children's Hospital Research Institute
Investigators
Principal Investigator: Gresham T Richter, MD UAMS, ACH
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01276860     History of Changes
Other Study ID Numbers: 112316
Study First Received: January 12, 2011
Last Updated: May 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
OSA
 PVT
Psychomotor Vigilance Testing
Psychomotor Vigilance Task

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013