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NCT Number: NCT01276860

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

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.

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Key information

Conditions

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

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 10-20 minutes each session, 3 sessions total

    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.

Secondary outcomes

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

    Time frame: 10-20 minute session, 1 session

    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. Outcome Measure is full completion of the PVT testing.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • Arkansas Children's Hospital Research Institute

Registry information

Acronym: PVT

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 13, 2011
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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