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NCT05757206 · ClinicalTrials.gov registry record
The Syn-Sleep Study
A clinical trial of REM Sleep Behavior Disorder (iRBD), sponsored by CND Life Sciences.
- Active
- Registry status
- 80
- Enrollment target
- 8
- Study locations
NCT05757206: Active study of REM Sleep Behavior Disorder (iRBD), sponsored by CND Life Sciences.
NCT05757206 is a study of REM Sleep Behavior Disorder (iRBD) that is active but no longer recruiting, run by CND Life Sciences. The registered enrollment target is 80 participants. The trial reports 8 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05757206, a study of REM Sleep Behavior Disorder (iRBD), is active but no longer recruiting, sponsored by CND Life Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- 80 participants
- Enrollment target
- 8
- Study locations
Study Summary
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.
Primary Outcome
Advance the diagnostic utility of the Syn-One Test™ by defining the metrics of P-SYN deposition and nerve fiber degeneration that predict phenoconversion in iRBD patients.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Syn-One Test
Study Locations (8)
Arizona
- MD First Research - Chandler
- Banner Health - Phoenix
- CND Life Sciences - Scottsdale
California
- Cedars Sinai Medical Center - Los Angeles
- Stanford Neuroscience Health Center - Palo Alto
Kentucky
- University of Kentucky - Lexington
New York
- Mount Sinai - New York
Texas
- Texas Institute for Neurological Disorders - Sherman
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-09-15 |
| Est. Completion | 2025-12-31 |
What the registry record for NCT05757206 still lists
NCT05757206 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target.
The record links to 1 condition, with REM Sleep Behavior Disorder (iRBD) appearing as the primary indexed condition, and to 1 intervention - of which Syn-One Test is the first listed.
NCT05757206 lists 8 locations in 5 states (Arizona, California, Kentucky).
Frequently Asked Questions
What is clinical trial NCT05757206 about?
NCT05757206 is a clinical study titled "The Syn-Sleep Study". 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...
What is the current status of trial NCT05757206?
This trial is currently active not recruiting. The enrollment target is 80 participants. The study started on 2022-09-15. Estimated completion is 2025-12-31.
What conditions does trial NCT05757206 study?
This clinical trial studies the following conditions: REM Sleep Behavior Disorder (iRBD).
What interventions are being tested in trial NCT05757206?
The interventions under investigation include: Syn-One Test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05757206?
This trial is sponsored by CND Life Sciences, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05757206 being conducted?
This trial has 8 study locations across Arizona, California, Kentucky, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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