NCT02766595

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 10, 2016

Completed
22 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 10, 2016

Status Verified

March 1, 2016

Enrollment Period

7 months

First QC Date

March 10, 2016

Last Update Submit

May 5, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (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

    6 months

Study Arms (1)

hyperventilation

OTHER

Non-drug: performing hyperventilation while sitting up during routine EEG

Other: hyperventilation while sitting up during routine EEG

Interventions

Child will be asked to perform hyperventilation while lying down as well as while sitting up

hyperventilation

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children referred for a routine EEG for suspected absence epilepsy

You may not qualify if:

  • Patients unable to perform hyperventilation
  • Children previously diagnosed with absence epilepsy
  • Children receiving antiepileptic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Epilepsy, Absence

Condition Hierarchy (Ancestors)

Epilepsy, GeneralizedEpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic Syndromes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2016

First Posted

May 10, 2016

Study Start

June 1, 2016

Primary Completion

January 1, 2017

Study Completion

June 1, 2017

Last Updated

May 10, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share