N/A
Completed N=7
The Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea
Source: ClinicalTrials.gov NCT01276860 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Number of Participants Who Achieved Criteria of Obstructive Sleep Apnea in the PVT Assessment — 5; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Achieved Criteria of Obstructive Sleep Apnea in the PVT Assessment |
5; 2 | — |
| SECONDARY Number of Participants Who Achieved Criteria of No Sleep Complaints in the PVT Assessment |
5; 2 | — |
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
Data sourced from ClinicalTrials.gov (NCT01276860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.