Trial Outcomes & Findings for The Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea (NCT NCT01276860)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

10-20 minutes each session, 3 sessions total

Results posted on

2021-05-05

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Group PVT subjects with sleep complaints.	Control Group PVT subjects without sleep complaints.
Overall Study STARTED	5	2
Overall Study COMPLETED	5	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=5 Participants 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.	Control Group n=2 Participants 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.	Total n=7 Participants Total of all reporting groups
Age, Customized 6-18 years	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=5 Participants PVT subjects with sleep complaints/Obstructive Sleep Apnea.	Control Group n=2 Participants PVT subjects without sleep complaints.
Number of Participants Who Achieved Criteria of Obstructive Sleep Apnea in the PVT Assessment	5 Participants	2 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=5 Participants PVT subjects with sleep complaints/Obstructive Sleep Apnea.	Control Group n=2 Participants PVT subjects without sleep complaints.
Number of Participants Who Achieved Criteria of No Sleep Complaints in the PVT Assessment	5 Participants	2 Participants

Adverse Events

Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Research Coordinator

Arkansas Children's Hospital

Phone: 501-364-2018

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place