NCT02514291

Brief Summary

The purpose of the study is to develop and evaluate a sleep intervention program for improving sleep and health in youth with epilepsy and their parents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

July 28, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
29 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

December 12, 2018

Status Verified

April 1, 2017

Enrollment Period

3 years

First QC Date

July 28, 2015

Last Update Submit

December 10, 2018

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Objective sleep

    Actigraphic assessed sleep variables

    12-month follow-up

Study Arms (2)

Sleep intervention

EXPERIMENTAL

Standard pediatric neurology care plus education and augmented support around adequate sleep habits, appropriate daylight exposure, and beneficial and safe physical activity tailored to each epileptic child's capabilities.

Behavioral: Sleep intervention

Standard care

NO INTERVENTION

Standard pediatric neurology care

Interventions

Sleep interventionBEHAVIORAL

Standard pediatric neurology care plus education and augmented support around adequate sleep habits, appropriate daylight exposure, and beneficial and safe physical activity tailored to each epileptic child's capabilities.

Sleep intervention

Eligibility Criteria

Age18 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged between 1.5 and 6 years with a confirmed diagnosis of epilepsy based on clinical and electro-encephalogram examinations.

You may not qualify if:

  • Children born before 37 weeks gestation, children with evidence of structural brain damage, or with cerebral palsy or those who are bedridden.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (2)

  • Tsai SY, Lee WT, Lee CC, Jeng SF, Weng WC. Behavioral-educational sleep interventions for pediatric epilepsy: a randomized controlled trial. Sleep. 2020 Jan 13;43(1):zsz211. doi: 10.1093/sleep/zsz211.

    PMID: 31552428DERIVED

  • Tsai SY, Lee WT, Lee CC, Jeng SF, Weng WC. Sleep in children with epilepsy: the role of maternal knowledge of childhood sleep. Sleep. 2018 Nov 1;41(11). doi: 10.1093/sleep/zsy157.

    PMID: 30137598DERIVED

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Shao-Yu Tsai, PhD

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2015

First Posted

August 3, 2015

Study Start

September 1, 2015

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

December 12, 2018

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)