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Clinical Trials/NCT02514291
NCT02514291
Completed
Not Applicable

Evaluation of a Clinic-based Sleep Intervention for Pediatric Epilepsy

National Taiwan University Hospital1 site in 1 country100 target enrollmentSeptember 1, 2015
ConditionsEpilepsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epilepsy
Sponsor
National Taiwan University Hospital
Enrollment
100
Locations
1
Primary Endpoint
Objective sleep
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2015
End Date
August 31, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Objective sleep

Time Frame: 12-month follow-up

Actigraphic assessed sleep variables

Study Sites (1)

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