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Sleep Intervention for Pediatric Epilepsy

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Sleep intervention
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

18 Months - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sleep intervention

Standard care

Arm Description

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.

Standard pediatric neurology care

Outcomes

Primary Outcome Measures

Objective sleep
Actigraphic assessed sleep variables

Secondary Outcome Measures

Full Information

First Posted
July 28, 2015
Last Updated
December 10, 2018
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02514291
Brief Title
Sleep Intervention for Pediatric Epilepsy
Official Title
Evaluation of a Clinic-based Sleep Intervention for Pediatric Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Sleep problems are more prevalent and serious in children with epilepsy whose sleep can be disrupted by seizures occurring during the night and/or during the day. Inadequate sleep has long been recognized as a trigger for seizure and poor sleep habits have been associated with unfavorable outcomes in children with epilepsy. Attention to sleep in children with epilepsy as a result is critically important for seizure control and health-related quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Standard pediatric neurology care
Intervention Type
Behavioral
Intervention Name(s)
Sleep intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective sleep
Description
Actigraphic assessed sleep variables
Time Frame
12-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children aged between 1.5 and 6 years with a confirmed diagnosis of epilepsy based on clinical and electro-encephalogram examinations. Exclusion Criteria: Children born before 37 weeks gestation, children with evidence of structural brain damage, or with cerebral palsy or those who are bedridden.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shao-Yu Tsai, PhD
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31552428
Citation
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.
Results Reference
derived
PubMed Identifier
30137598
Citation
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.
Results Reference
derived

Learn more about this trial

Sleep Intervention for Pediatric Epilepsy

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