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Idiopathic Hypersomnia clinical trials

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NCT ID: NCT05458128 Active, not recruiting - Clinical trials for Idiopathic Hypersomnia

A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia

Start date: August 19, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the long-term safety and effectiveness of pitolisant in patients with idiopathic hypersomnia (IH) who completed the Double-Blind Randomized Withdrawal Phase of study HBS-101-CL-010.

NCT ID: NCT05371483 Enrolling by invitation - Narcolepsy Clinical Trials

Cardiovascular and Cognitive Implications of Central Disorders of Hypersomnolence and Their Treatments

Start date: May 18, 2022
Phase:
Study type: Observational

This is an observational study evaluating patients diagnosed with narcolepsy or idiopathic hypersomnia that have been prescribed a new/different hypersomnia treatment. The study is being done to better understand how hypersomnia treatment(s) impact blood pressure and cognitive function.

NCT ID: NCT05321355 Recruiting - Insomnia Clinical Trials

Mainz Register of Patients With Sleep Disorders

MAINZ-SLEEPREG
Start date: February 1, 2022
Phase:
Study type: Observational [Patient Registry]

Prospective longitudinal observational registry study of all patients with sleep disorders treated in the Mainz Comprehensive Epilepsy and Sleep Medicine Center with the focus on the course of the disease and quality of life.

NCT ID: NCT05156047 Completed - Clinical trials for Idiopathic Hypersomnia

A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia

Start date: May 25, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in patients with idiopathic hypersomnia (IH) age ≥18 years. Key secondary objectives of this study are to assess the impact of pitolisant on: - Overall symptoms of IH - Patient impression of overall change in their symptoms of IH - Investigator assessment of overall disease severity of IH Other secondary objectives of this study are to assess the impact of pitolisant in patients with IH on: - Patient impression of overall severity of their EDS - Functional status and activities of daily living - Sleep-related impairment - Sleep inertia - Cognitive function

NCT ID: NCT05150977 Completed - Clinical trials for Hypersomnia, Idiopathic

Idiopathic Hypersomnia

IDAHO
Start date: December 1, 2021
Phase:
Study type: Observational

Idiopathic hypersomnia (IH) is characterized by non-restoring night-time sleep, excessive daytime sleepiness, sleep inertia, impaired cognitive functioning and autonomic symptoms. IH seems to be long lasting, once established, but little is known about long-time consequences, and research on the relationship between idiopathic hypersomnia and all-cause mortality is however sparse. IH is thus a poorly characterized disorder of hypersomnolence, and the present study aims to answer the following research questions: 1. Are there subgroups within the IH-group, that can be retrospectively characterized out of data from polysomnography, PSG and MSLT. 2. What are the relationships between IH, and possible IH subgroups, and morbidity, mortality, and sick leave, using retrospective register data? 3. What is the natural course of IH, and possible IH subgroups, assessed with questionnaires that measures daytime sleepiness, depression, and insomnia? 4. How do subjects diagnosed with IH think about their disease, cope with it, and perceive the effects of treatments, using qualitative interviews? 185 individuals assessed and diagnosed at the Sleep unit, Uppsala university hospital between 2010-01-01 and 2019-12-31 will be contacted. After collecting informed consents, PSG and MSLT data will be analysed together with register data regarding morbidity, mortality, sick leave, and pharmacotherapy.Questionnaires used at the time of the original assessment will be reviewed and, to study the natural course of the syndrome, the same questionnaires will be sent to the participants by mail.

NCT ID: NCT04827329 Completed - Clinical trials for Restless Legs Syndrome

Anesthetic Management of Patients With Chronic Sleep Disorders

ANEST-SLEEP
Start date: March 1, 2021
Phase:
Study type: Observational

The aim of this study is to describe and compare the anaesthesia history and possible problems encountered in 3 groups of patients with 3 chronic sleep diseases: narcolepsy, idiopathic hypersomnia, and restless legs syndrome followed at the Montpellier Sleep Unit. For each participant, existing data from the medical record will be used, with their consent. All participants will complete a standardized questionnaire, concerning their history of anaesthesia, the course and possible complications, and questions about their treatment for their sleep disorder.

NCT ID: NCT04330963 Recruiting - Narcolepsy Clinical Trials

International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study

iSPHYNCS
Start date: January 6, 2020
Phase:
Study type: Observational [Patient Registry]

Swiss Primary Hypersomnolence and Narcolepsy Cohort Study (SPHYNCS) is a cohort study on disease presentation and long-term course with an exploratory approach to detect biomarkers.

NCT ID: NCT04091438 Completed - Clinical trials for Idiopathic Hypersomnia

A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia

Start date: January 26, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of administering a single intravenous (IV) infusion dose of TAK-925 to adult participants with idiopathic hypersomnia (IH).

NCT ID: NCT04026958 Recruiting - Clinical trials for Idiopathic Hypersomnia

Clarithromycin Mechanisms in Hypersomnia Syndromes

Start date: September 4, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate a medication called clarithromycin for treating sleepiness in narcolepsy and idiopathic hypersomnia. Studies have shown that clarithromycin can reduce sleepiness, but researchers do not know how clarithromycin does this. This study will look at brain activity (on magnetic resonance imaging [MRI]), inflammation, bacteria living in the gut, and cerebrospinal fluid, to better understand how clarithromycin can reduce sleepiness. This study will recruit 92 participants who will be randomized to receive clarithromycin or a placebo for 14 days.

NCT ID: NCT03904238 Completed - Narcolepsy Clinical Trials

Psychosocial Adjunctive Treatment for Hypersomnia (PATH)

Start date: December 10, 2018
Phase: N/A
Study type: Interventional

Current pharmacological treatments for chronic hypersomnia (narcolepsy, idiopathic hypersomnia) can effectively reduce excessive daytime sleepiness but a high proportion of patients experience depressive symptoms and poor health-related quality of life. Unfortunately, there are currently no psychosocial interventions that directly addresses this issue. Therefore, the overall goal of this project is to gather initial outcome data and work out methodological issues to determine if a future pragmatic clinical trial is warranted.