Pediatric Obstructive Sleep Apnea
Conditions
Keywords
Obstructive Sleep Apnea, Pediatric Obstructive Sleep Apnea, OSA, PVT, Psychomotor Vigilance Testing, Psychomotor Vigilance Task
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.
Interventions
DEVICEPsychomotor 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.
Sponsors
Arkansas Children's Hospital Research Institute
University of Arkansas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved Criteria of Obstructive Sleep Apnea in the PVT Assessment | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved Criteria of No Sleep Complaints in the PVT Assessment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group PVT subjects with sleep complaints.Control subjects will be asked to participate in one session. Treatment subjects will be asked to participate in 3 sessions. | 5 |
| Control Group PVT subjects without sleep complaints.Control subjects will be asked to participate in one session. Treatment subjects will be asked to participate in 3 sessions. | 2 |
| Total | 7 |
Baseline characteristics
| Characteristic | Treatment Group | Control Group | Total |
|---|---|---|---|
| Age, Customized 6-18 years | 5 Participants | 2 Participants | 7 Participants |
| Region of Enrollment United States | 5 participants | 2 participants | 7 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 2 |
| other Total, other adverse events | 0 / 5 | 0 / 2 |
| serious Total, serious adverse events | 0 / 5 | 0 / 2 |
Outcome results
Primary
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
Population: The analysis of each participant is based on the timing between hearing a specific tone or seeing a flashing light and the pressing of the button to record the alertness and attentiveness. Finalized analysis is not completed as the study was ended early and data not analyzed to compare groups.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Number of Participants Who Achieved Criteria of Obstructive Sleep Apnea in the PVT Assessment | 5 Participants |
| Control Group | Number of Participants Who Achieved Criteria of Obstructive Sleep Apnea in the PVT Assessment | 2 Participants |
Secondary
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
Population: The analysis of each participant is based on the timing between hearing a specific tone or seeing a flashing light and the pressing of the button to record the alertness and attentiveness. Finalized analysis is not completed as the study was ended early and data not analyzed to compare groups.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Number of Participants Who Achieved Criteria of No Sleep Complaints in the PVT Assessment | 5 Participants |
| Control Group | Number of Participants Who Achieved Criteria of No Sleep Complaints in the PVT Assessment | 2 Participants |