Spots Global Cancer Trial Database for Characterizing Sleep Disorders in Children and Adults With Tuberous Sclerosis Complex (TSC)
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Trial Identification
Brief Title: Characterizing Sleep Disorders in Children and Adults With Tuberous Sclerosis Complex (TSC)
Official Title: Characterizing Sleep Disorders in Children and Adults With Tuberous Sclerosis Complex (TSC)
Study ID: NCT03326765
Conditions
Study Description
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.
Detailed Description: 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.
Eligibility
Minimum Age: 1 Day
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
Universitair Ziekenhuis Brussel, Jette, Vlaams Brabant, Belgium
Contact Details
Name: Anna Jansen, PhD, MD
Affiliation: Universitair Ziekenhuis Brussel
Role: PRINCIPAL_INVESTIGATOR
Name: Sonia De Weerdt, MD
Affiliation: Universitair Ziekenhuis Brussel
Role: PRINCIPAL_INVESTIGATOR
Name: Alessandra Pereira,, PhD, MD
Affiliation: Department of Pediatrics School of Medicine, PUCRS, Brazil
Role: PRINCIPAL_INVESTIGATOR
Name: Magda Nunes, PhD, MD
Affiliation: Director, School of Medicine, PUCRS, Brazil; Brain Instititute of Rio Grande do Sul, Brazil
Role: PRINCIPAL_INVESTIGATOR
Name: Oliviero Bruni, PhD, MD
Affiliation: Department of Developmental and Social Psychology, Sapienza University of Rome, Italy
Role: PRINCIPAL_INVESTIGATOR
Name: Paolo Curatolo, PhD, MD
Affiliation: Director, Child Neurology and Psychiatry Unit, Systems Medicine Department, Tor Vergata University of Rome, Italy
Role: PRINCIPAL_INVESTIGATOR
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