The Syn-Sleep Study

NCT05757206 | Active Not Recruiting

• 1 other identifier: 102
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 8

Brief 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

REM Sleep Behavior Disorder (iRBD)

Outcome Measures

Primary Outcomes (2)

• Advance the diagnostic utility of the Syn-One Test

  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.

  3 years

• Enhance pathological reading through digital quantitative analysis of the Syn-One Test

  Enhance pathological reading through digital quantitative analysis of the Syn-One Test™ using an AI-augmented detection system. Whole slide imaging with extraction of representative neural structures, target stain detection, segmentation, stain quantification and pattern recognition will be performed using deep learning algorithms. Results will be compared against pathologist readings and actual follow-up data to further refine model accuracy.

  3 years

Interventions

Syn-One Test DIAGNOSTIC_TEST

Participating subjects will have three small skin punch biopsies.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Gender at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

80 subjects diagnosed with iRBD

You may qualify if:

• Males and females age 18-85
• Subjects will have repeated episodes of sleep related vocalizations and/or complex motor behaviors
• Sleep-related behaviors/disturbances must be documented by polysomnography to occur during REM sleep
• Polysomnographic recording is consistent with REM sleep without atonia

You may not qualify if:

• Subjects with MoCA \< 19, Hoehn and Yahr score \>/=1, contraindications to skin biopsy
• Diagnosis of Parkinson's disease
• Diagnosis of dementia of any type
• Diagnosis of multiple system atrophy
• REM sleep behaviors/disturbances secondary to another cause (e.g., narcolepsy, dementia, and Parkinson's disease)
• Contra-indications to skin biopsy:
• Clinical evidence of severe vascular disease (history of ulceration, poor wound healing, and vascular claudication)
• History of allergic reaction to local anesthesia for skin biopsies
• Use of blood thinners (aspirin of Plavix alone is allowed)
• Significantly impaired wound healing or history of scarring or keloid formation

Sponsors & Collaborators

• CND Life Sciences: lead

Study Sites (8)

MD First Research

Chandler, Arizona, 85286, United States

Location

Banner Health

Phoenix, Arizona, 85006, United States

Location

CND Life Sciences

Scottsdale, Arizona, 85258, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Stanford Neuroscience Health Center

Palo Alto, California, 94304, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Mount Sinai

New York, New York, 10003, United States

Location

Texas Institute for Neurological Disorders

Sherman, Texas, 75092, United States

Location

MeSH Terms

Conditions

REM Sleep Behavior Disorder

Condition Hierarchy (Ancestors)

REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Todd Levine

  CND Life Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 7, 2023
• Study Start: September 15, 2022
• Primary Completion: December 17, 2025
• Study Completion: December 31, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

US (8)