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

Sleep Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03326765
• Other study ID #: TSC v 1.0
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2017
• Est. completion date: November 30, 2019

Study information

• Verified date: October 2018
• Source: Universitair Ziekenhuis Brussel
• Contact: Veerle Van Mossevelde, Study coordinator
• Phone: +3224763134
• Email: veerle.vanmossevelde[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 30, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Parasomnias
• Sclerosis
• Sleep Disorder
• Sleep Wake Disorders
• Tuberous Sclerosis

Intervention

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
• 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

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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