Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03326765
Recruitment Status : Unknown
Verified October 2018 by Veerle Van Mossevelde, Universitair Ziekenhuis Brussel.
Recruitment status was:  Recruiting
First Posted : October 31, 2017
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Veerle Van Mossevelde, Universitair Ziekenhuis Brussel

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.

Condition or disease Intervention/treatment Phase
Sleep Disorder Other: Questionnaires Procedure: electroencephalogram (EEG) Procedure: polysomnography Procedure: Actigraphy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

2 groups:

  • 30 Children(0-18y) withTSC without epilepsy
  • 30 Adults(>18y) withTSC without epilepsy
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Characterizing Sleep Disorders in Children and Adults With Tuberous Sclerosis Complex (TSC)
Actual Study Start Date : September 27, 2017
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 30, 2019


Arm Intervention/treatment
Children
Questionnaires electroencephalogram (EEG) Actigraphy polysomnography
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

Adults
Questionnaires electroencephalogram (EEG) Actigraphy polysomnography
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




Primary Outcome Measures :
  1. characterize the sleep phenotype of TSC in children and adults without epilepsy [ Time Frame: 1 night ]
    - Sleep efficiency (SE%): the percentage ratio between total sleep time and time in bed (TST/TIB*100)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326765


Contacts
Layout table for location contacts
Contact: Veerle Van Mossevelde, Study coordinator +3224763134 veerle.vanmossevelde@uzbrussel.be
Contact: Dirk De Clippeleir, Study coordinator +3224763580 dirk.declippeleir@uzbrussel.be

Locations
Layout table for location information
Belgium
Universitair Ziekenhuis Brussel Recruiting
Jette, Vlaams Brabant, Belgium, 1090
Contact: Veerle Van Mossevelde, Datanurse    +3224763134    veerle.vanmossevelde@uzbrussel.be   
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
Layout table for investigator information
Principal Investigator: 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
Layout table for additonal information
Responsible Party: Veerle Van Mossevelde, Study coordinator, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03326765    
Other Study ID Numbers: TSC v 1.0
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Veerle Van Mossevelde, Universitair Ziekenhuis Brussel:
tuberous sclerosis complex (TSC)
Children
Adults
Additional relevant MeSH terms:
Layout table for MeSH terms
Tuberous Sclerosis
Sleep Wake Disorders
Parasomnias
Sclerosis
Pathologic Processes
Nervous System Diseases
Neurologic Manifestations
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
Genetic Diseases, Inborn