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Does Body Positioning Affect the Yield of Hyperventilation in Routine Pediatric Electroencephalography - EEG Studies?

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ClinicalTrials.gov Identifier: NCT02766595
Recruitment Status : Unknown
Verified March 2016 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 10, 2016
Last Update Posted : May 10, 2016
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

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.

Condition or disease Intervention/treatment Phase
Epilepsy, Absence Other: hyperventilation while sitting up during routine EEG Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : June 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arm Intervention/treatment
hyperventilation
Non-drug: performing hyperventilation while sitting up during routine EEG
Other: hyperventilation while sitting up during routine EEG
Child will be asked to perform hyperventilation while lying down as well as while sitting up




Primary Outcome Measures :
  1. Differences in elapsed time (in seconds) to onset of absence seizure between lying supine and sitting up during hyperventilation in routine EEG. [ Time Frame: 6 months ]
    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 :
  1. 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 [ Time Frame: 6 months ]
    Response A: 0 - 60 secs; response B: 60 - 120 seconds; response C: no occurrence of absence



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Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT02766595     History of Changes
Other Study ID Numbers: 0257-15-MMC
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hyperventilation
Epilepsy, Absence
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Epilepsy, Generalized
Epileptic Syndromes