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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05757206
The ClinicalTrials.gov registry entry for NCT05757206 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CND Life Sciences, which has 8 total studies on file at ClinicalTrials.gov.
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 reports 8 study locations spanning 5 distinct geographic areas - top geographies include 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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