Pediatric Obstructive Sleep ApneaPVTNCT01276860
The Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea
A study testing Psychomotor Vigilance Testing in people with Pediatric Obstructive Sleep Apnea, run by University of Arkansas at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obstructive Sleep Apnea
- What is being tested?
- Psychomotor Vigilance Testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
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.
- Conditions
- Pediatric Obstructive Sleep Apnea
- Being tested
- Psychomotor Vigilance Testing
- Keywords
- Obstructive Sleep Apnea, Pediatric Obstructive Sleep Apnea, OSA, PVT, Psychomotor Vigilance Testing, Psychomotor Vigilance Task
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychomotor Vigilance TestingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Psychomotor Vigilance Testing | Other | 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. Receives: Device: Psychomotor Vigilance Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10-20 minutes each session, 3 sessions total
Secondary outcomes (1)
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.
Measured: 10-20 minute session, 1 session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startMay 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Arkansas Children's Hospital Research Institute
- Responsible party
- Sponsor
- Investigators
- Gresham T Richter, MD, Principal investigator, UAMS, ACH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276860
- Sponsor's protocol ID
- 112316
- Acronym
- PVT
- Status last verified
- May 2021
- First submitted
- 12 Jan 2011
- Last updated
- 5 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01276860
- Acronym / sponsor ID
- PVT / 112316
- Conditions
- Pediatric Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Pediatric Obstructive Sleep Apnea, OSA, PVT, Psychomotor Vigilance Testing, Psychomotor Vigilance Task
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Arkansas Children's Hospital Research Institute
- Study start
- May 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 13 Jan 2011 (estimated)
- Results
- Posted 12 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychomotor Vigilance Testing | Other | Device: Psychomotor Vigilance TestingThe 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychomotor Vigilance TestingThe 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 |
Primary outcome
Number of Participants Who Achieved Criteria of Obstructive Sleep Apnea in the PVT Assessment
Time frame: 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.
1 secondary outcome
Number of Participants Who Achieved Criteria of No Sleep Complaints in the PVT Assessment
Time frame: 10-20 minute session, 1 session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pediatric Obstructive Sleep Apnea
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
RecruitingObservational study
Development of a Multimodal Deep Learning Model for Pediatric Patients
Pediatric Obstructive Sleep Apnea, Polysomnography
Not yet recruiting
Pediatric/Adolescent WatchPAT 400 Reliability Pilot Study
Pediatric Sleep Disordered Breathing, Obstructive Sleep Apnea
RecruitingObservational study
Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing
Early Risk Screening for Sleep Disordered Breathing in a Dental Setting, Sleep Disordered Breathing (SDB)
Recruiting
Photobiomodulation for Pediatric Hypertrophic Tonsils
Pediatric Sleep Apnea, Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gresham T Richter, MD principal investigator
UAMS, ACH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychomotor Vigilance Testing in people with Pediatric Obstructive Sleep Apnea, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Achieved Criteria of Obstructive Sleep Apnea in the PVT Assessment (time frame: 10-20 minutes each session, 3 sessions total). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.