Characterizing Sleep Disorders in Children and Adults With Tuberous Sclerosis Complex (TSC)

Summary

The proposed research project is aimed at further characterization of sleep problems and evaluation of their impact in children and adults with TSC, excluding epilepsy as contributing factor. Questionnaire-based studies have shown that sleep problems occur in up to half of the children and a third of adults with tuberous sclerosis complex (TSC). However, there is only limited information on the nature of sleep problems and their impact on patients with TSC and their families.

Conditions

• Sleep Disorder

Interventions

OTHER

Questionnaires

* Epworth sleepiness scale * Pittsburgh sleep quality Index (PSQI) * EQ-5D Adults * Pediatric Daytime Sleepiness scale (PDSS) * Sleep disturbance Scale for Children (SDSC * EQ-5D Children * Sleaping diary

PROCEDURE

electroencephalogram (EEG)

is an electrophysiological monitoring method to record electrical activity of the brain

PROCEDURE

polysomnography

type of sleep study, is a multi-parametric test used in the study of sleep and as a diagnostic tool in sleep medicine

PROCEDURE

Actigraphy

type of sleep study based on bracelet around the wrist

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel

  lead OTHER

Principal Investigators

• Anna Jansen, PhD, MD · Universitair Ziekenhuis Brussel

• Sonia De Weerdt, MD · Universitair Ziekenhuis Brussel

• Alessandra Pereira,, PhD, MD · Department of Pediatrics School of Medicine, PUCRS, Brazil

• Magda Nunes, PhD, MD · Director, School of Medicine, PUCRS, Brazil; Brain Instititute of Rio Grande do Sul, Brazil

• Oliviero Bruni, PhD, MD · Department of Developmental and Social Psychology, Sapienza University of Rome, Italy

• Paolo Curatolo, PhD, MD · Director, Child Neurology and Psychiatry Unit, Systems Medicine Department, Tor Vergata University of Rome, Italy

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-09-27

Primary Completion

2019-11-01

Completion

2019-11-30

Countries

• Belgium

Study Locations