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

NCT03326765 | Unknown

• 1 other identifier: TSC v 1.0
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

tuberous sclerosis complex (TSC); Children; Adults

Outcome Measures

Primary Outcomes (1)

• characterize the sleep phenotype of TSC in children and adults without epilepsy

  \- Sleep efficiency (SE%): the percentage ratio between total sleep time and time in bed (TST/TIB\*100)

  1 night

Study Arms (2)

Children

OTHER

Questionnaires electroencephalogram (EEG) Actigraphy polysomnography

Other: Questionnaires; Procedure: electroencephalogram (EEG); Procedure: polysomnography; Procedure: Actigraphy

Adults

OTHER

Questionnaires electroencephalogram (EEG) Actigraphy polysomnography

Other: Questionnaires; Procedure: electroencephalogram (EEG); Procedure: polysomnography; Procedure: Actigraphy

Interventions

Questionnaires OTHER

* 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

Adults; Children

electroencephalogram (EEG) PROCEDURE

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

Adults; Children

polysomnography PROCEDURE

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

Adults; Children

Actigraphy PROCEDURE

type of sleep study based on bracelet around the wrist

Adults; Children

Eligibility Criteria

• Age: 1 Day - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Children and adults with definite TSC based on the 2012 Consensus Conference Diagnostic

You may not qualify if:

• daily alcohol intake
• pregnancy
• caffeine abuse (\>4 cups/day)
• shift work
• drug abuse
• anti-depressive therapy
• medications as benzodiazepine, melatonin, phenobarbital and antihistamines
• the presence of clinical or electrographic seizures.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Vlaams Brabant, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Sleep Wake Disorders; Tuberous Sclerosis

Interventions

Surveys and Questionnaires; Actigraphy

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Hamartoma; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Accelerometry

Study Officials

• Anna Jansen, PhD, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

• Sonia De Weerdt, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

• Alessandra Pereira,, PhD, MD

  Department of Pediatrics School of Medicine, PUCRS, Brazil

  PRINCIPAL INVESTIGATOR

• Magda Nunes, PhD, MD

  Director, School of Medicine, PUCRS, Brazil; Brain Instititute of Rio Grande do Sul, Brazil

  PRINCIPAL INVESTIGATOR

• Oliviero Bruni, PhD, MD

  Department of Developmental and Social Psychology, Sapienza University of Rome, Italy

  PRINCIPAL INVESTIGATOR

• Paolo Curatolo, PhD, MD

  Director, Child Neurology and Psychiatry Unit, Systems Medicine Department, Tor Vergata University of Rome, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veerle Van Mossevelde, Study coordinator

CONTACT

+3224763134; veerle.vanmossevelde@uzbrussel.be

Dirk De Clippeleir, Study coordinator

CONTACT

+3224763580; dirk.declippeleir@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study coordinator

Model Details: 2 groups: * 30 Children(0-18y) withTSC without epilepsy * 30 Adults(\>18y) withTSC without epilepsy

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: October 31, 2017
• Study Start: September 27, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 30, 2019
• Last Updated: October 17, 2018

Record last verified: 2018-10

Locations

BE (1)