Sleep DisorderNCT03326765
Characterizing Sleep Disorders in Children and Adults With Tuberous Sclerosis Complex (TSC)
A study testing Questionnaires, electroencephalogram (EEG) and polysomnography in people with Sleep Disorder, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 1 day to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- Questionnaires, electroencephalogram (EEG) and polysomnography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Sep 2017to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Children and adults with definite TSC based on the 2012 Consensus Conference Diagnostic
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Jette, Vlaams Brabant, 1090
Veerle Van Mossevelde, Datanurse, +3224763134, veerle.vanmossevelde@uzbrussel.be
About this study
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.
Read the 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.
- Conditions
- Sleep Disorder
- Being tested
- Questionnaires, electroencephalogram (EEG), polysomnography, Actigraphy
- Keywords
- tuberous sclerosis complex (TSC), Children, Adults
- Medical subject headings
- Sleep Wake Disorders, Tuberous Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
- 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
electroencephalogram (EEG)Procedure or surgery
is an electrophysiological monitoring method to record electrical activity of the brain
polysomnographyProcedure or surgery
type of sleep study, is a multi-parametric test used in the study of sleep and as a diagnostic tool in sleep medicine
ActigraphyProcedure or surgery
type of sleep study based on bracelet around the wrist
| Study group | Role | What they receive |
|---|---|---|
| Children | Other | Questionnaires electroencephalogram (EEG) Actigraphy polysomnography Receives: Other: Questionnaires; Procedure: electroencephalogram (EEG); Procedure: polysomnography; Procedure: Actigraphy |
| Adults | Other | Questionnaires electroencephalogram (EEG) Actigraphy polysomnography Receives: Other: Questionnaires; Procedure: electroencephalogram (EEG); Procedure: polysomnography; Procedure: Actigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start27 Sep 2017
- Primary completion1 Nov 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups: * 30 Children(0-18y) withTSC without epilepsy * 30 Adults(\>18y) withTSC without epilepsy
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veerle Van Mossevelde, Universitair Ziekenhuis Brussel
- Investigators
- Anna Jansen, PhD, MD, Principal investigator, Universitair Ziekenhuis BrusselSonia De Weerdt, MD, Principal investigator, Universitair Ziekenhuis BrusselAlessandra Pereira,, PhD, MD, Principal investigator, Department of Pediatrics School of Medicine, PUCRS, BrazilMagda Nunes, PhD, MD, Principal investigator, Director, School of Medicine, PUCRS, Brazil; Brain Instititute of Rio Grande do Sul, BrazilOliviero Bruni, PhD, MD, Principal investigator, Department of Developmental and Social Psychology, Sapienza University of Rome, ItalyPaolo Curatolo, PhD, MD, Principal investigator, Director, Child Neurology and Psychiatry Unit, Systems Medicine Department, Tor Vergata University of Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326765
- Sponsor's protocol ID
- TSC v 1.0
- Status last verified
- Oct 2018
- First submitted
- 6 Oct 2017
- Last updated
- 17 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Sleep Disorders in Children and Adults With Tuberous Sclerosis Complex (TSC)
- ClinicalTrials.gov ID
- NCT03326765
- Acronym / sponsor ID
- TSC v 1.0
- Conditions
- Sleep Disorder
- Keywords
- tuberous sclerosis complex (TSC), Children, Adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 27 Sep 2017 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups: * 30 Children(0-18y) withTSC without epilepsy * 30 Adults(>18y) withTSC without epilepsy
| Arm | Type | Receives |
|---|---|---|
| Children | Other | Other: Questionnaires, Procedure: electroencephalogram (EEG), Procedure: polysomnography, Procedure: ActigraphyQuestionnaires electroencephalogram (EEG) Actigraphy polysomnography |
| Adults | Other | Other: Questionnaires, Procedure: electroencephalogram (EEG), Procedure: polysomnography, Procedure: ActigraphyQuestionnaires electroencephalogram (EEG) Actigraphy polysomnography |
Who may qualify
- Ages
- 1 day to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Children and adults with definite TSC based on the 2012 Consensus Conference Diagnostic
Key exclusion criteria (8 listed)
- daily alcohol intake
- pregnancy
- caffeine abuse (>4 cups/day)
- shift work
- drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Adults, Children |
| electroencephalogram (EEG)is an electrophysiological monitoring method to record electrical activity of the brain | Procedure or surgery | Adults, Children |
| polysomnographytype of sleep study, is a multi-parametric test used in the study of sleep and as a diagnostic tool in sleep medicine | Procedure or surgery | Adults, Children |
| Actigraphytype of sleep study based on bracelet around the wrist | Procedure or surgery | Adults, Children |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Jansen, PhD, MD principal investigator
Universitair Ziekenhuis Brussel
Sonia De Weerdt, MD principal investigator
Universitair Ziekenhuis Brussel
Alessandra Pereira,, PhD, MD principal investigator
Department of Pediatrics School of Medicine, PUCRS, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires, electroencephalogram (EEG) and polysomnography in people with Sleep Disorder, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veerle Van Mossevelde, Study coordinator (+3224763134, veerle.vanmossevelde@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
characterize the sleep phenotype of TSC in children and adults without epilepsy (time frame: 1 night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.