Characterizing Sleep Disorders in Children and Adults With Tuberous Sclerosis Complex (TSC)
NCT ID: NCT03326765
Last Updated: 2018-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2017-09-27
2019-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
* 30 Children(0-18y) withTSC without epilepsy
* 30 Adults(\>18y) withTSC without epilepsy
OTHER
NONE
Study Groups
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Children
Questionnaires electroencephalogram (EEG) Actigraphy polysomnography
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
electroencephalogram (EEG)
is an electrophysiological monitoring method to record electrical activity of the brain
polysomnography
type of sleep study, is a multi-parametric test used in the study of sleep and as a diagnostic tool in sleep medicine
Actigraphy
type of sleep study based on bracelet around the wrist
Adults
Questionnaires electroencephalogram (EEG) Actigraphy polysomnography
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
electroencephalogram (EEG)
is an electrophysiological monitoring method to record electrical activity of the brain
polysomnography
type of sleep study, is a multi-parametric test used in the study of sleep and as a diagnostic tool in sleep medicine
Actigraphy
type of sleep study based on bracelet around the wrist
Interventions
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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
electroencephalogram (EEG)
is an electrophysiological monitoring method to record electrical activity of the brain
polysomnography
type of sleep study, is a multi-parametric test used in the study of sleep and as a diagnostic tool in sleep medicine
Actigraphy
type of sleep study based on bracelet around the wrist
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
1 Day
70 Years
ALL
Yes
Sponsors
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Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Veerle Van Mossevelde
Study coordinator
Principal Investigators
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Anna Jansen, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Universitair Ziekenhuis Brussel
Sonia De Weerdt, MD
Role: PRINCIPAL_INVESTIGATOR
Universitair Ziekenhuis Brussel
Alessandra Pereira,, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatrics School of Medicine, PUCRS, Brazil
Magda Nunes, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Director, School of Medicine, PUCRS, Brazil; Brain Instititute of Rio Grande do Sul, Brazil
Oliviero Bruni, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Developmental and Social Psychology, Sapienza University of Rome, Italy
Paolo Curatolo, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Director, Child Neurology and Psychiatry Unit, Systems Medicine Department, Tor Vergata University of Rome, Italy
Locations
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Universitair Ziekenhuis Brussel
Jette, Vlaams Brabant, Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TSC v 1.0
Identifier Type: -
Identifier Source: org_study_id
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