NCT03896386

Brief Summary

During a three-month period, the study subjects will be using an electronic diary app that they can download and install on their smartphones to register the occurrence of seizures and also to register the potential alerting behaviour of their dogs. This information will increase the knowledge of the accuracy of these alerts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
227

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
Last Updated

January 6, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

February 4, 2019

Last Update Submit

January 5, 2023

Conditions

Epilepsy

Keywords

EpilepsySeizuresSeizure alert dogsSeizure diary

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity across all dogs.

    Percentage of dog alerts followed by a seizure, percentage of seizures preceded by a dog alert

    3 months

Secondary Outcomes (2)

  • Differences between trained and untrained dogs

    3 months

  • Correlation between alerting behaviour and pre-ictal symptoms

    3 months

Study Arms (1)

Use of seizure diary

OTHER

People diagnosed with epilepsy that lives with a dog that is able to anticipate the onset of a seizure. They will be ask to use a diary (bespoke smartphone app) to register the occurrence of seizures and the alerting behaviour of the dogs.

Other: Use of seizure diary

Interventions

Use of seizure diaryOTHER

The participants will press the "alert" button when they witness and alerting behaviour on their dogs or the "Seizure" button when they had experienced a seizure. We will receive this information live through the app back-end

Use of seizure diary

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The volunteer has been diagnosed with epilepsy by a neurologist and lives with a dog that anticipates the occurrence of seizures (trained or not)
  • Volunteers should be able to operate an electronic diary app on a smartphone by themselves or will have an assistant/carer with them 24/24 that will operate the device for them.
  • In the case of children, the parents/tutors will fill in the diary for them.
  • In the case of people with learning disabilities, carers or familiars will fill in the diary for them.

You may not qualify if:

  • \- People with non-epileptic seizures, that are not able to use a smartphone's app or that can't provide us with a confirmation of their diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology - Ghent University Hospital

Ghent, Flanders, 9000, Belgium

Location

Related Publications (5)

  • Brown SW, Goldstein LH. Can Seizure-Alert Dogs predict seizures? Epilepsy Res. 2011 Dec;97(3):236-42. doi: 10.1016/j.eplepsyres.2011.10.019. Epub 2011 Nov 1.

    PMID: 22050976BACKGROUND

  • McEntegart D. Are electronic diaries useful for symptoms research? A systematic review. J Psychosom Res. 2007 Oct;63(4):453. doi: 10.1016/j.jpsychores.2007.08.003. No abstract available.

    PMID: 17905056BACKGROUND

  • Kirton A, Winter A, Wirrell E, Snead OC. Seizure response dogs: evaluation of a formal training program. Epilepsy Behav. 2008 Oct;13(3):499-504. doi: 10.1016/j.yebeh.2008.05.011. Epub 2008 Jul 1.

    PMID: 18595778BACKGROUND

  • Flegg PJ. Seizure-alerting and -response behaviors in dogs living with epileptic children. Neurology. 2005 Feb 8;64(3):581; author reply 581. doi: 10.1212/wnl.64.3.581. No abstract available.

    PMID: 15699414BACKGROUND

  • Stone AA, Shiffman S, Schwartz JE, Broderick JE, Hufford MR. Patient compliance with paper and electronic diaries. Control Clin Trials. 2003 Apr;24(2):182-99. doi: 10.1016/s0197-2456(02)00320-3.

    PMID: 12689739BACKGROUND

MeSH Terms

Conditions

EpilepsySeizures

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christel Moons, PhD

    Faculty of Veterinary Medicine, Ghent

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 4, 2019

First Posted

April 1, 2019

Study Start

September 1, 2017

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

January 6, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)