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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03326765
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Universitair Ziekenhuis Brussel
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Anna Jansen, PhD, MDSonia De Weerdt, MDAlessandra Pereira,, PhD, MDMagda Nunes, PhD, MDOliviero Bruni, PhD, MDPaolo Curatolo, PhD, MD
Principal Investigator Affiliation Universitair Ziekenhuis BrusselUniversitair Ziekenhuis BrusselDepartment of Pediatrics School of Medicine, PUCRS, BrazilDirector, School of Medicine, PUCRS, Brazil; Brain Instititute of Rio Grande do Sul, BrazilDepartment of Developmental and Social Psychology, Sapienza University of Rome, ItalyDirector, Child Neurology and Psychiatry Unit, Systems Medicine Department, Tor Vergata University of Rome, Italy
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Belgium
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Sleep Disorder
Additional Details

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. It is known from a questionnaire-based study in children with TSC that they often wake early or wake frequently during the night, and that they can be more tired during the day. In some children, sleep-problems seem to be related to the presence of seizures during the night. This has been confirmed in a study on 10 children with TSC and epilepsy by a combination of polysomnography (sleep study) and electroencephalography (EEG). A questionnaire-based study in adults also revealed the association with epilepsy features, and showed influence of mental health complaints on sleep. Sleep structure and quality will be assessed through formal sleep studies (polysomnography and actigraphy). The influence of abnormal brain activity on sleep will be mapped by simultaneous recording of brain activity by means of EEG. The impact of sleep disorders will be determined through interviews with individuals with TSC and their relatives. The investigators will also use questionnaires and diaries to supplement their findings. Importance: It is expected that the results of this study will 1) improve our understanding of sleep problems in TSC, 2) provide additional information on the influence of TSC on sleep, 3) give a more in-depth view on the impact of sleep problems on the lives of individuals with TSC and their families, 4) increase awareness about sleep problems in TSC, and 5) contribute to a better management of sleep problems by patients and families.

Contact a Trial Team

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International Sites

Universitair Ziekenhuis Brussel, Jette, Vlaams Brabant, Belgium

Status

Recruiting

Address

Universitair Ziekenhuis Brussel

Jette, Vlaams Brabant, 1090

Site Contact

Veerle Van Mossevelde, Datanurse

veerle.vanmossevelde@uzbrussel.be

+3224763134

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