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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03326765
Other study ID # TSC v 1.0
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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