Idiopathic Hypersomnia Clinical Trial
Official title:
The Role of the Circadian System in Neurological Sleep-wake Disorders: Assessment of Circadian and Homeostatic Sleep-wake Regulation and Vigilance With a Poly-nap Protocol
The aim of this study is to investigate the role of the circadian system in patients with neurologic sleep-wake disorders. Therefore, overnight sleep will be distributed over 30 hours into repetitive sleep-wake cycles (poly-nap protocol), so that sleep episodes occur at different circadian phases. Vigilance, attention, risk behavior as well as sleep onset latency will be observed. Ambulatory accelerometer recordings gain more and more attention in the diagnostic work-up of sleep disorders, as they allow to also include the everyday rest-activity rhythm before examinations in the sleep laboratory. Advances of novel devices should improve the detection of rest and activity and therefore the estimation of sleep and wake, especially in patients with neurologic sleep-wake disorders exhibiting fragmented sleep. Two types of actimeters will be applied throughout our study protocol to explore better classification of sleep and wake phases and patterns of the rest-activity rhythm. This study is designed as an observational case-controlled study targeting the disorders of narcolepsy type 1 and idiopathic hypersomnia, and including interventional procedures in the healthy control group (sleep deprivation, sleep restriction) in a counter-balanced design.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04026958 -
Clarithromycin Mechanisms in Hypersomnia Syndromes
|
Phase 2 | |
| Completed |
NCT02512588 -
A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2
|
Phase 2 | |
| Completed |
NCT01183312 -
Flumazenil for the Treatment of Primary Hypersomnia
|
Phase 1/Phase 2 | |
| Completed |
NCT03597555 -
Sodium Oxybate in Idiopathic Hypersomnia
|
Phase 2/Phase 3 | |
| Completed |
NCT03533114 -
A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
|
Phase 3 | |
| Active, not recruiting |
NCT03542851 -
A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia
|
Phase 2 | |
| Completed |
NCT05156047 -
A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia
|
Phase 3 | |
| Enrolling by invitation |
NCT05371483 -
Cardiovascular and Cognitive Implications of Central Disorders of Hypersomnolence and Their Treatments
|
||
| Not yet recruiting |
NCT06252571 -
a Chronobiological Treatment Combining Evening Melatonin and Morning Light Therapy in Idiopathic Hypersomnia: a Prospective, Double Bind, Randomized, Placebo-controlled -Trial
|
Phase 2 | |
| Completed |
NCT04827329 -
Anesthetic Management of Patients With Chronic Sleep Disorders
|
||
| Recruiting |
NCT05875974 -
Ph4 PSG Combined JZP258-407
|
Phase 4 | |
| Recruiting |
NCT01793168 -
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
|
||
| Completed |
NCT01146600 -
Clarithromycin for the Treatment of Hypersomnia
|
Phase 2 | |
| Recruiting |
NCT04330963 -
International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study
|
||
| Not yet recruiting |
NCT05615584 -
Spectrometry (MRM) Versus I 125 Radioimmunoassay (RIA) for Quantification of Orexin-A of Patients With Hypersomnolence
|
N/A | |
| Completed |
NCT04091438 -
A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia
|
Phase 1 | |
| Recruiting |
NCT05837091 -
Low Sodium Oxybate in Patients With Idiopathic Hypersomnia
|
Phase 4 | |
| Recruiting |
NCT05321355 -
Mainz Register of Patients With Sleep Disorders
|
||
| Active, not recruiting |
NCT05668754 -
Placebo-Controlled, Double-Blind, Study to Determine the Safety and Efficacy of SDX in Patients With IH
|
Phase 2 | |
| Not yet recruiting |
NCT06153615 -
Local Sleep in Idiopathic Hypersomnia
|
N/A |