Back to resultsThe Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea (PVT)
Primary Purpose
Pediatric Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychomotor Vigilance Testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Pediatric Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, Pediatric Obstructive Sleep Apnea, OSA, PVT, Psychomotor Vigilance Testing, Psychomotor Vigilance Task
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
Sites / Locations
- Arkansas Children's Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Psychomotor Vigilance Testing
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants Who Achieved Criteria of No Sleep Complaints in the PVT Assessment
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.
Full Information
NCT ID
NCT01276860
First Posted
January 12, 2011
Last Updated
May 3, 2021
Sponsor
University of Arkansas
Collaborators
Arkansas Children's Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01276860
Brief Title
The Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea
Acronym
PVT
Official Title
The Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
Arkansas Children's Hospital Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obstructive Sleep Apnea
Keywords
Obstructive Sleep Apnea, Pediatric Obstructive Sleep Apnea, OSA, PVT, Psychomotor Vigilance Testing, Psychomotor Vigilance Task
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psychomotor Vigilance Testing
Arm Type
Other
Arm Description
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
Intervention Name(s)
Psychomotor Vigilance Testing
Intervention Description
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 Outcome Measure Information:
Title
Number of Participants Who Achieved Criteria of Obstructive Sleep Apnea in the PVT Assessment
Description
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.
Time Frame
10-20 minutes each session, 3 sessions total
Secondary Outcome Measure Information:
Title
Number of Participants Who Achieved Criteria of No Sleep Complaints in the PVT Assessment
Description
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.
Time Frame
10-20 minute session, 1 session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gresham T Richter, MD
Organizational Affiliation
UAMS, ACH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea
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