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

Pediatric Obstructive Sleep Apnea Clinical Trial

— PVT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01276860
• Other study ID #: 112316
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Est. completion date: September 2011

Study information

• Verified date: May 2021
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Pediatric Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	Arkansas Children's Hospital	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	10-20 minutes each session, 3 sessions total
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.	10-20 minute session, 1 session