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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02851199
• Other study ID #: HYMC-0043-16
• Status: Recruiting
• Phase: N/A
• First received: July 28, 2016
• Last updated: August 2, 2016
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: Hillel Yaffe Medical Center
• Contact: Muhammad Mahajna, MD PHD
• Phone: 972506246959
• Email: mohamedm[@]hy.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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:

1. 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

2. 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 10 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Epilepsy
• Hyperventilation

Intervention

Device:
• Electroencephalography
Electroencephalograph recording following hyperventilation in different participant's body postures

Locations

Country	Name	City	State
Israel	Hillel Yaffe medical center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 day	No