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Sleep Intervention for Pediatric Epilepsy

NCT ID: NCT02514291

Last Updated: 2018-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2018-08-31

Brief Summary

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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

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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.

Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Sleep intervention

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.

Group Type EXPERIMENTAL

Sleep intervention

Intervention Type BEHAVIORAL

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 care

Standard pediatric neurology care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sleep intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shao-Yu Tsai, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 31552428 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30137598 (View on PubMed)

Other Identifiers

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201412211RINA

Identifier Type: -

Identifier Source: org_study_id