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The Syn-Sleep Study
NCT05757206 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 36 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05757206 reports 8 study locations spanning 5 distinct geographic areas — top geographies include Arizona, California, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05757206?
The interventions under investigation include: Syn-One Test (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05757206?
This trial is sponsored by CND Life Sciences, which has 36 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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