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REM Sleep Behavior Disorder clinical trials

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NCT ID: NCT06329453 Recruiting - Multiple Sclerosis Clinical Trials

Intestinal Immunity in Neurologic Disease

Start date: August 2, 2022
Phase:
Study type: Observational

The purpose of this study is to ascertain the functional profiles of the immune cells within the gastrointestinal tract and to determine how these cells contribute to autoimmune and neurologic diseases.

NCT ID: NCT06270290 Recruiting - Concussion, Brain Clinical Trials

The COSP-RBD Study: Concussions and Contact Sports in RBD vs Controls

COSP-RBD
Start date: April 22, 2024
Phase:
Study type: Observational

The goal of this observational study is to investigate concussions and contact sports practices in REM sleep behaviour disorder (RBD). The main questions it aims to answer are: - What is the proportion of patients with RBD that have a history of concussions or exposure to contact sports? - Is this proportion higher to that in control patients without a diagnosis of RBD? Participants will undergo an interview with a sleep medicine specialist to answer questions about history of concussions and contact sports practices. Researchers will compare an RBD group and a control group (without RBD) to see if the proportion of concussions and exposure to contact sports differ.

NCT ID: NCT06193252 Recruiting - Parkinson Disease Clinical Trials

Slow-SPEED-NL: Slowing Parkinson's Early Through Exercise Dosage-Netherlands

Slow-SPEED-NL
Start date: January 15, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to investigate the feasibility if a remotely administered smartphone app can increase the volume and intensity of physical activity in daily life in patients with isolated Rapid Eye Movement (REM) sleep behaviour disorder over a long period of time (24 months). Participants will be tasked to achieve an incremental increase of daily steps (volume) and amount of minutes exercised at a certain heart rate (intensity) with respect to their own baseline level. Motivation with regards to physical activity will entirely be communicated through the study specific Slow Speed smartphone app. Primary outcomes will be compliance expressed as longitudinal change in digital measures of physical activity (step count) measured using a Fitbit smartwatch. Exploratory outcomes entail retention rate, completeness of remote digital biomarker assessments, digital prodromal motor and non-motor features of PD, blood biomarkers and brain imaging markers. Using these biomarkers, we aim to develop a composite score (prodromal load score) to estimate the total prodromal load. An international exercise study with fellow researchers in the United States and United Kingdom are currently in preparation (Slow-SPEED). Our intention is to analyse overlapping outcomes combined where possible through a meta-analysis plan, to obtain insight on (determinants of) heterogeneity in compliance and possible efficacy across subgroups

NCT ID: NCT06140511 Not yet recruiting - Clinical trials for REM Sleep Behavior Disorder

DREAMER - IsolateD REM Sleep Without Atonia as a Risk Factor for REM Sleep Behavior disordER

DREAMER
Start date: November 20, 2023
Phase:
Study type: Observational

This study aims at the constitution of a large cohort of adult subjects without Rapid eye movement (REM) sleep behavior disorder (RBD), among whom subjects with isolated REM sleep without atonia (RSWA) will be identified; their long-term follow-up, compared to subjects without RSWA, will be useful in the next years to understand if this condition represents a risk factor for the future development of RBD, a condition in which the development of a neurodegenerative disorder (especially synucleinopathy) is highly probable. This will allow to obtain a wide time window for the establishment of prevention and neuroprotection in these subjects, with the goal to avoid or delay the development of the RBD>synucleinopathy sequence. All Units will recruit a large number of subjects without RBD undergoing a polysomnography (PSG) recording, with a shared protocol, and the data collected will be stored on a web-based common database. Subjects showing RSWA in their PSG will be identified and used as a prospective study group, which will start at the end of the recruitment of this project.

NCT ID: NCT05976971 Recruiting - Clinical trials for REM Sleep Behaviour Disorder

Microstructural and Sodium 7 Tesla Brain MRI in Idiopathic REM Sleep Behaviour Disorder

SODISLEEP
Start date: October 30, 2023
Phase: N/A
Study type: Interventional

By 2030 the number of patients with Parkinson's Disease (PD) would increase by 56% affecting 1 out of 120 people older than 45 years-old. It is known that 10-15 years before the onset motor symptoms such as tremor, rigidity and akinesia, patients often experience a specific sleep trouble called REM sleep behaviour disorder (RBD). Follow-up of those subjects showed there was a conversion rate to PD and related disorders (called synucleinopathies) over 80%. The pathophysiology of RBD is poorly understood. The development of cutting-edge technologies such as 7 Tesla MRI and the optimisation of image processing methods made it possible to non-invasively explore in vivo small brain structures involved in sleep and movement disorders. The investigators hypothesize that brain and brainstem microstructure, composition, sodium homeostasis and connectivity may change in 15 isolated RBD (iRBD) subjects compared with 15 healthy controls and that these changes may be correlated with clinical scores. This study would help fill the gap in early diagnosis of synucleinopathies, by contributing to better targeting patients who could be included in therapeutic trials with a neuroprotective effect. Besides, the exploration of original pathophysiological pathways such as sodium homeostatis could provide the necessary arguments for the development of new target therapeutics.

NCT ID: NCT05922995 Not yet recruiting - Clinical trials for REM Behavior Disorder

The Effects of Tasimelteon in Participants With REM Behavior Disorder (RBD)

RBD
Start date: September 30, 2023
Phase: Early Phase 1
Study type: Interventional

To assess the effects of a daily single oral dose of 20 mg tasimelteon compared to baseline on events of dream enactment on patients with REM Behavior Disorder, as measured by a daily log. To assess the effects of 20 mg tasimelteon compared to baseline on insomnia= symptoms, as measured by validated questionnaires (Insomnia Severity Index [ISI], Pittsburgh Sleep Quality Inventory [PSQI], Epworth Sleepiness Scale [ESS], Clinical Global Impression of Change Scale (CGI-C), Patient Global Impression of Change Scale (PGI-C)) as well as rest/activity pattern from actigraphy. - To assess the effects of 20 mg tasimelteon on patients who have a reduced or aberrant melatonin secretion compared to normal secretion by measuring salivary DLMO at baseline and correlating with the degree of change in RBD symptoms by end of the study. - To assess for any role a patient's unique genome may play in their response to tasimelteon; obtained via whole genome sequencing. - To assess the safety and tolerability of a daily single oral dose of 20 mg tasimelteon.

NCT ID: NCT05904717 Recruiting - Clinical trials for REM Sleep Behavior Disorder

Effect of PXS-4728A on Microglia Activation in Participants With Isolated Rapid Eye Movement Sleep Behaviour Disorder

Start date: November 8, 2023
Phase: Phase 2
Study type: Interventional

This study is to investigate the safety and efficacy of PXS-4728A as an intervention therapy in participants with iRBD. This study will be conducted in participants aged 50 to 80 years of age and will investigate a single dose level.

NCT ID: NCT05826457 Recruiting - Parkinson Disease Clinical Trials

North American Prodromal Synucleinopathy Consortium Stage 2

NAPS2
Start date: August 12, 2022
Phase:
Study type: Observational

This study will enroll participants with idiopathic REM sleep behavior disorder (RBD) and healthy controls for the purpose of preparing for a clinical trial of neuroprotective treatments against synucleinopathies.

NCT ID: NCT05757206 Recruiting - Clinical trials for REM Sleep Behavior Disorder (iRBD)

The Syn-Sleep Study

Start date: September 15, 2022
Phase:
Study type: Observational

In collaboration with approximately 8 centers that specialize in iRBD we will recruit a total of 80 individuals for the study. All subjects will be enrolled into a 2-year longitudinal study where skin biopsies will be performed at 3 sites on each patient at 12-month intervals (baseline, year 1, year 2). Plasma blood collection will be performed at 12-month intervals (baseline, year 1, year 2). Detailed quantified examination, cognitive evaluation, medical history, and questionnaires will be performed at each visit. Additional biomarker, imaging and clinical information (if available) will be obtained for the purpose of determining phenoconversion to clinically apparent synucleinopathy. Subjects enrolled in the study will have baseline evaluations and follow up visits at 12 and 24 months to define any changes to clinical diagnosis (clinical phenoconversion). Skin biopsies will be repeated at the 12- and 24-month follow up visits to determine the rate of P-SYN accumulation over time and the rates of nerve fiber degeneration within punch skin biopsies.

NCT ID: NCT05721911 Not yet recruiting - Parkinson Disease Clinical Trials

Implementing a National Biobank of PD With WGS and Functional Assessment of Polygenic Inheritance by iPSC Technology

Start date: June 2023
Phase:
Study type: Observational

The genetic complexity and heterogeneity of the sporadic forms of Parkinson's disease (PD) are posing a formidable challenge to disentangle their direct molecular causes. To advance this research, we plan to coordinate our local biorepositories of PD biological specimens creating a standardized and integrated national resource. In this framework, we plan to collect more samples from additional sporadic PD cases and to extend the sampling to patients with REM sleep behavior disease. We plan a large campaign of whole genome sequencing including about 200 patients to identify rare genomic variants plausibly associated with these diseases. In addition, we will standardize the generation and quality control of iPSC lines to make available to the scientific community. Finally, we will combine iPSC technology and gene editing to functionally assess the relative impact of rare variants in coding regions inherited together as a polygenic trait previously identified in selected sporadic PD cases