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

Sponsor

Meir Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02766595

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy, Absence	Other: hyperventilation while sitting up during routine EEG	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

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 :

Jun 1, 2016

Anticipated Primary Completion Date :

Jan 1, 2017

Anticipated Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Arm

Intervention/Treatment

Other: 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

Outcome Measures

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. [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

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 [6 months]
Response A: 0 - 60 secs; response B: 60 - 120 seconds; response C: no occurrence of absence

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 10 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Meir Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Meir Medical Center

ClinicalTrials.gov Identifier:

NCT02766595

Other Study ID Numbers:

0257-15-MMC

First Posted:

May 10, 2016

Last Update Posted:

May 10, 2016

Last Verified:

Mar 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Hyperventilation

Epilepsy, Absence

Study Results

No Results Posted as of May 10, 2016