Does Body Positioning Affect the Yield of Hyperventilation in Routine Pediatric Electroencephalography - EEG Studies?
Primary Purpose
Epilepsy, Absence
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hyperventilation while sitting up during routine EEG
Sponsored by
About this trial
This is an interventional diagnostic trial for Epilepsy, Absence
Eligibility Criteria
Inclusion Criteria:
- Children referred for a routine EEG for suspected absence epilepsy
Exclusion Criteria:
- Patients unable to perform hyperventilation
- Children previously diagnosed with absence epilepsy
- Children receiving antiepileptic drugs
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
hyperventilation
Arm Description
Non-drug: performing hyperventilation while sitting up during routine EEG
Outcomes
Primary Outcome Measures
Differences in elapsed time (in seconds) to onset of absence seizure between lying supine and sitting up during hyperventilation in routine EEG.
patients to be divided into 3 groups: Response A: occurrence of absence within 0-60 seconds; response B: within 60 - 120 seconds; response C: no occurrence of absence.
Secondary Outcome Measures
Influence of order of performing hyperventilation, first supine and then sitting up, or vice-versa, on the time (in seconds) to occurrence of ansence seizures
Response A: 0 - 60 secs; response B: 60 - 120 seconds; response C: no occurrence of absence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02766595
Brief Title
Does Body Positioning Affect the Yield of Hyperventilation in Routine Pediatric Electroencephalography - EEG Studies?
Official Title
Hyperventilation During Routine EEG in Children: the Impact of Body Position - Sitting vs Supine- on the Yield of the Procedure in Provoking Absence Seizures
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Children referred for routine EEG studies for suspected absence seizures will be asked, upon caregiver's informed consent, to perform 3 minutes of hyperventilation both in the supine position and while sitting up. We aim to demonstrate that hyperventilation is more effective in eliciting absence seizures in a sitting position than while lying down.
Detailed Description
Hyperventilation is a very effective means of eliciting absence seizures in children with absence epilepsy. Worldwide EEG protocols for routine EEG recording include 3 minutes of hyperventilation. The whole EEG recording, including hyperventilation, is performed with the child lying down on a bed/coach. Our clinical experience suggests that the body position may affect the yield of hyperventilation in provoking the absence event. That is, hyperventilation may be more effective when the child is sitting up, Therefore, children referred for a routine EEG for suspected absence seizures will add 3 minutes of hyperventilation on a sitting position to the routine 3 minutes of supine hyperventilation. At least 5 minutes of rest will be allotted between both procedures.
Patients' caregivers will sign an informed consent form. Patients will randomly be divided into 2 groups: one group will first perform supine hyperventilation followed by sitting hyperventilation; the second group will perform hyperventilation in the opposite order, ie, first sitting up and then in supine position.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Absence
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hyperventilation
Arm Type
Other
Arm Description
Non-drug: performing hyperventilation while sitting up during routine EEG
Intervention Type
Other
Intervention Name(s)
hyperventilation while sitting up during routine EEG
Intervention Description
Child will be asked to perform hyperventilation while lying down as well as while sitting up
Primary Outcome Measure Information:
Title
Differences in elapsed time (in seconds) to onset of absence seizure between lying supine and sitting up during hyperventilation in routine EEG.
Description
patients to be divided into 3 groups: Response A: occurrence of absence within 0-60 seconds; response B: within 60 - 120 seconds; response C: no occurrence of absence.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Influence of order of performing hyperventilation, first supine and then sitting up, or vice-versa, on the time (in seconds) to occurrence of ansence seizures
Description
Response A: 0 - 60 secs; response B: 60 - 120 seconds; response C: no occurrence of absence
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children referred for a routine EEG for suspected absence epilepsy
Exclusion Criteria:
Patients unable to perform hyperventilation
Children previously diagnosed with absence epilepsy
Children receiving antiepileptic drugs
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Does Body Positioning Affect the Yield of Hyperventilation in Routine Pediatric Electroencephalography - EEG Studies?
We'll reach out to this number within 24 hrs