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The Syn-Sleep Study

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 15, 2025 (before its estimated December 17, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Aug 31, 2025 to Dec 17, 2025
    • Study completion date: Aug 31, 2025 to Dec 31, 2025
    • Site details revised at 8 of 8 sites
    v6
  2. Re-verified, no change to tracked fieldsv5
  3. Study sites: 7 to 8v4
  4. Study sites: 6 to 7v3
  5. Trial status: Active, Not Recruiting to Recruiting
    • Study sites: 1 to 6
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05757206
Lead Sponsor CND Life Sciences
Conditions
(from sponsor)		 REM Sleep Behavior Disorder (iRBD)
Related terms REM Sleep Behavior Disorder
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov