Clinical trial · Interventional
Characterizing Sleep Disorders in Children and Adults With Tuberous Sclerosis Complex (TSC)
NCT03326765CI-TRIAL-00035339unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sleep Disorder | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Actigraphy | Procedure | — | UNRESOLVED |
| electroencephalogram (EEG) | Procedure | — | UNRESOLVED |
| polysomnography | Procedure | — | UNRESOLVED |
| Questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Children
- description
- Questionnaires electroencephalogram (EEG) Actigraphy polysomnography
- interventionNames
- Other: Questionnaires
- Procedure: electroencephalogram (EEG)
- Procedure: polysomnography
- Procedure: Actigraphy
- type
- OTHER
- label
- Adults
- description
- Questionnaires electroencephalogram (EEG) Actigraphy polysomnography
- interventionNames
- Other: Questionnaires
- Procedure: electroencephalogram (EEG)
- Procedure: polysomnography
- Procedure: Actigraphy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Day
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.