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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
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epilepsy, Absence

Eligibility Criteria

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

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

    First Posted
    March 10, 2016
    Last Updated
    May 5, 2016
    Sponsor
    Meir Medical Center
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    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

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