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The Effect of Child Position on the Results of Hyperventilation During Routine Electroencephalography

Primary Purpose

Epilepsy

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Electroencephalography
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epilepsy

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • children suspected of having absence seizures in the ages mentioned above.
  • legal guardian approval

Exclusion Criteria:

  • inability to perform hyperventilation
  • children who have absence seizure under anti-convulsive treatment

Sites / Locations

  • Hillel Yaffe medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

study group 1

study group 2

Arm Description

1. A group of 15 children who will undergoe an electroencephlaography recording with 3 minutes of hyperventilation in the prone position, followed by 5 minutes of rest, then after another 5-10 minutes of recording with normal breathing. Finally the participants will performed additional 3 minutes of hyperventilation in the sitting position

2. A group of 15 children who will undergoe an electroencephlaography recording with 3 minutes of hyperventilation in the sitting position, followed by 5 minutes of rest, then after another 5-10 minutes of recording with normal breathing. . Finally the participants will performed additional 3 minutes of hyperventilation in the

Outcomes

Primary Outcome Measures

epileptic discharge measurement
The analysis of the study results will be performed by a specialist in pediatric neurology and pediatric epilepsy who will confirm whether the EEG recording show epileptic discharge (sharp waves, slow waves, combination of sharp and slow waves, spikes or combination of spikes and slow waves)

Secondary Outcome Measures

Full Information

First Posted
July 28, 2016
Last Updated
August 2, 2016
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02851199
Brief Title
The Effect of Child Position on the Results of Hyperventilation During Routine Electroencephalography
Official Title
The Effect of Child Position on the Results of Hyperventilation During Routine Electroencephalography
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Electroencephalograhy (EEG) is used as a tool for diagnosing epilepsy/convulsions. During the recording, especially for childen who are suspected of having abbcence epilepsy the investigators will perform an EEG recording including a provocation test of hyperventilation in order to induce epileptic discharges. There is no clear instruction about the position of the child during performing this hyperventilation provocation. Clinical observations showed that this provocation is more effective when it's performed in the siiting position. No study was previously performed to investigate this issue
Detailed Description
The study will include 30 patients at the age of 4-10 years old of both sexes. after signing an informed concent, every child, suspected of having absence seizures, will undergoe an EEG recording including a provocation of hyperventilation. The study will include two groups: A group of 15 children who will undergoe an EEG recording with 3 minutes of hyperventilation in the prone position, followed by 5 minutes of rest, then after another 5-10 minutes of recording with normal breathing. Finally the participants will performed additional 3 minutes of hyperventilation in the sitting position A group of 15 children who will undergoe an EEG recording with 3 minutes of hyperventilation in the sitting position, followed by 5 minutes of rest, then after another 5-10 minutes of recording with normal breathing. . Finally the participants will performed additional 3 minutes of hyperventilation in the prone position. Participants who will not be able to perform all the steps of the study will be excluded The analysis of the study results will be performed by a specialist in pediatric neurology and pediatric epilepsy who will confirm whether the EEG recording show epileptic discharge (sharp waves, slow waves, combination of sharp and slow waves, spikes or combination of spikes and slow waves)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group 1
Arm Type
Active Comparator
Arm Description
1. A group of 15 children who will undergoe an electroencephlaography recording with 3 minutes of hyperventilation in the prone position, followed by 5 minutes of rest, then after another 5-10 minutes of recording with normal breathing. Finally the participants will performed additional 3 minutes of hyperventilation in the sitting position
Arm Title
study group 2
Arm Type
Active Comparator
Arm Description
2. A group of 15 children who will undergoe an electroencephlaography recording with 3 minutes of hyperventilation in the sitting position, followed by 5 minutes of rest, then after another 5-10 minutes of recording with normal breathing. . Finally the participants will performed additional 3 minutes of hyperventilation in the
Intervention Type
Device
Intervention Name(s)
Electroencephalography
Intervention Description
Electroencephalograph recording following hyperventilation in different participant's body postures
Primary Outcome Measure Information:
Title
epileptic discharge measurement
Description
The analysis of the study results will be performed by a specialist in pediatric neurology and pediatric epilepsy who will confirm whether the EEG recording show epileptic discharge (sharp waves, slow waves, combination of sharp and slow waves, spikes or combination of spikes and slow waves)
Time Frame
1 day

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 suspected of having absence seizures in the ages mentioned above. legal guardian approval Exclusion Criteria: inability to perform hyperventilation children who have absence seizure under anti-convulsive treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Mahajna, MD PHD
Phone
972506246959
Email
mohamedm@hy.health.gov.il
Facility Information:
Facility Name
Hillel Yaffe medical center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Mahajna, MD PHD
Phone
972506246959
Email
mohamedm@hy.health.gov.il

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
25661285
Citation
Watemberg N, Farkash M, Har-Gil M, Sezer T, Goldberg-Stern H, Alehan F. Hyperventilation during routine electroencephalography: are three minutes really necessary? Pediatr Neurol. 2015 Apr;52(4):410-3. doi: 10.1016/j.pediatrneurol.2014.12.003. Epub 2014 Dec 31.
Results Reference
background
PubMed Identifier
19632158
Citation
Hughes JR. Absence seizures: a review of recent reports with new concepts. Epilepsy Behav. 2009 Aug;15(4):404-12. doi: 10.1016/j.yebeh.2009.06.007. Epub 2009 Jul 24.
Results Reference
background
PubMed Identifier
20378290
Citation
Ma X, Zhang Y, Yang Z, Liu X, Sun H, Qin J, Wu X, Liang J. Childhood absence epilepsy: Elctroclinical features and diagnostic criteria. Brain Dev. 2011 Feb;33(2):114-9. doi: 10.1016/j.braindev.2010.02.004. Epub 2010 Apr 7.
Results Reference
background

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The Effect of Child Position on the Results of Hyperventilation During Routine Electroencephalography

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