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

Not Applicable

• Conditions: Sleep Disorder
• Interventions: Other: Questionnaires; Procedure: electroencephalogram (EEG); Procedure: polysomnography; Procedure: Actigraphy

• Registration Number: NCT03326765
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2017-09-27
• Study First Submitted: 2017-10-06
• Study First Submitted QC: 2017-10-25
• Study First Posted: 2017-10-31
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-15
• Last Update Posted: 2018-10-17
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Children	Questionnaires	Questionnaires electroencephalogram (EEG) Actigraphy polysomnography
Children	polysomnography	Questionnaires electroencephalogram (EEG) Actigraphy polysomnography
Children	electroencephalogram (EEG)	Questionnaires electroencephalogram (EEG) Actigraphy polysomnography
Children	Actigraphy	Questionnaires electroencephalogram (EEG) Actigraphy polysomnography
Adults	Questionnaires	Questionnaires electroencephalogram (EEG) Actigraphy polysomnography
Adults	electroencephalogram (EEG)	Questionnaires electroencephalogram (EEG) Actigraphy polysomnography
Adults	polysomnography	Questionnaires electroencephalogram (EEG) Actigraphy polysomnography
Adults	Actigraphy	Questionnaires electroencephalogram (EEG) Actigraphy polysomnography

Primary Outcome Measures

Name	Time	Method
characterize the sleep phenotype of TSC in children and adults without epilepsy	1 night	- Sleep efficiency (SE%): the percentage ratio between total sleep time and time in bed (TST/TIB\*100)

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Vlaams Brabant, Belgium