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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

Tracking Information
First Submitted Date  ICMJE March 10, 2016
First Posted Date  ICMJE May 10, 2016
Last Update Posted Date May 10, 2016
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2016)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Body Positioning Affect the Yield of Hyperventilation in Routine Pediatric Electroencephalography - EEG Studies?
Official Title  ICMJE Hyperventilation During Routine EEG in Children: the Impact of Body Position - Sitting vs Supine- on the Yield of the Procedure in Provoking Absence Seizures
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Epilepsy, Absence
Intervention  ICMJE Other: hyperventilation while sitting up during routine EEG
Child will be asked to perform hyperventilation while lying down as well as while sitting up
Study Arms  ICMJE hyperventilation
Non-drug: performing hyperventilation while sitting up during routine EEG
Intervention: Other: hyperventilation while sitting up during routine EEG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 5, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02766595
Other Study ID Numbers  ICMJE 0257-15-MMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Meir Medical Center
Study Sponsor  ICMJE Meir Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Meir Medical Center
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP