An interventional study of Questionnaires and electroencephalogram (EEG) in Sleep Disorder, sponsored by Universitair Ziekenhuis Brussel. Status unknown at 1 site in Belgium. Open to participants aged 1 Day to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-17.
Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Other
Among 17 studies in Sleep Wake Disorders with a site in Belgium — 5 open to participants now, 8 under way, 4 of them phase 3. Sleep Wake Disorders · Belgium.
Among the 17 studies in Sleep Wake Disorders with a site in Belgium, this one is the 9th largest by planned enrollment of the 12 interventional ones that give a count, is the only one that started in 2017, is one of 6 with no phase, and was the 3rd registered.
747 studies on the registry are indexed under Sleep Wake Disorders; 182 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 531 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →5 of the 17 studies in Sleep Wake Disorders with a site in Belgium are open now, in 12 countries. Each count lists the studies.
Of the 109 Sleep Wake Disorders studies recruiting now, 36 (33%) set no upper age limit and 53 (49%) stop at 75 or younger; 22 take children under 18; 24 take healthy volunteers.
This study: 1 Day to 70 Years · all sexes · healthy volunteers too.
The full table on the hub →17 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 1 started in 2017.
Median enrollment 110 across the 12 interventional studies, 112 across the 5 observational. Of the 5 that completed or were terminated, 1 (20%) have results posted.
8 of 17 have an industry lead sponsor. The 10 most frequent:
Universitair Ziekenhuis Brussel is the lead sponsor of 375 studies on the registry; 107 are open to participants now.
Universitair Ziekenhuis Brussel has 1 study filed under Sleep Wake Disorders — fewer than ten, so there is no comparison to draw.
6 of the studies in Sleep Wake Disorders with a site in Belgium that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07502443Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2 | 2027-05 |
| NCT07455383Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 | 2027-05 |
| NCT07540897Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304) | 2027-06 |
| NCT06843590Alkermes, Inc.A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia | 2026-11 |
| NCT05387473Vrije Universiteit BrusselAdded Value of Cognitive Behavioural Therapy for Insomnia in Persons With Knee Osteoarthritis | 2026-12 |
Among the 17 studies in Sleep Wake Disorders with a site in Belgium, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Children and adults with definite TSC based on the 2012 Consensus Conference Diagnostic
Exclusion Criteria:
Questionnaires electroencephalogram (EEG) Actigraphy polysomnography
Other: Questionnaires · Procedure: electroencephalogram (EEG) · Procedure: polysomnography · Procedure: Actigraphy
Questionnaires electroencephalogram (EEG) Actigraphy polysomnography
Other: Questionnaires · Procedure: electroencephalogram (EEG) · Procedure: polysomnography · Procedure: Actigraphy
* 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
is an electrophysiological monitoring method to record electrical activity of the brain
type of sleep study, is a multi-parametric test used in the study of sleep and as a diagnostic tool in sleep medicine
type of sleep study based on bracelet around the wrist
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)
Time frame: 1 night
Started Sep 2017 (actual). Primary completion is estimated for Nov 2019, 25 months after the start.
Of 208 non-industry interventional studies with no phase under Sleep Wake Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 40. This study's planned 25 months is above that.
Counting every sponsor, half of 243 studies reached it within 19 months; a quarter within 6 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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