Sleep Intervention for Pediatric Epilepsy

Epilepsy Clinical Trial

Official title:

Evaluation of a Clinic-based Sleep Intervention for Pediatric Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02514291
• Other study ID #: 201412211RINA
• Status: Completed
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: August 31, 2018

Study information

• Verified date: April 2017
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective sleep	Actigraphic assessed sleep variables	12-month follow-up