An interventional study of Psychomotor Vigilance Testing in Pediatric Obstructive Sleep Apnea, sponsored by University of Arkansas. Completed at 1 site in United States. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-05.
Sponsored by University of Arkansas · Not applicable, Interventional, and Diagnostic
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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This study's enrollment of 7 is below the median of 50 across 965 interventional studies indexed under Apnea.
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Exclusion Criteria:
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
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.
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.
Time frame: 10-20 minutes each session, 3 sessions total
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.
Time frame: 10-20 minute session, 1 session
| Milestone | Treatment Group | Control Group |
|---|---|---|
| Started | 5 | 2 |
| Completed | 5 | 2 |
| Not completed | 0 | 0 |
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.
| Participants | Treatment Group | Control Group |
|---|---|---|
| Number of Participants Who Achieved Criteria of Obstructive Sleep Apnea in the PVT Assessment | 5 | 2 |
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.
| Participants | Treatment Group | Control Group |
|---|---|---|
| Number of Participants Who Achieved Criteria of No Sleep Complaints in the PVT Assessment | 5 | 2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Group | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Control Group | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Customized(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| 6-18 years | 5 | 2 | 7 |
| Sex: Female, Male(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 5 | 2 | 7 |
| Region of Enrollment(participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| United States | 5 | 2 | 7 |
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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University of Arkansas