The Syn-Sleep Study

N/AActive Not RecruitingNCT05757206

CND Life Sciences80 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

REM Sleep Behavior Disorder (iRBD)

Interventions

Syn-One TestDIAGNOSTIC_TEST

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Males and females age 18-85 2. Subjects will have repeated episodes of sleep related vocalizations and/or complex motor behaviors 3. Sleep-related behaviors/disturbances must be documented by polysomnography to occur during REM sleep 4. Polysomnographic recording is consistent with REM sleep without atonia Exclusion Criteria: 1. Subjects with MoCA \< 19, Hoehn and Yahr score \>/=1, contraindications to skin biopsy 2. Diagnosis of Parkinson's disease 3. Diagnosis of dementia of any type 4. Diagnosis of multiple system atrophy 5. REM sleep behaviors/disturbances secondary to another cause (e.g., narcolepsy, dementia, and Parkinson's disease) 6. Contra-indications to skin biopsy: 1. Clinical evidence of severe vascular disease (history of ulceration, poor wound healing, and vascular claudication) 2. History of allergic reaction to local anesthesia for skin biopsies 3. Use of blood thinners (aspirin of Plavix alone is allowed) 4. Significantly impaired wound healing or history of scarring or keloid formation

Locations (8)

MD First Research

Chandler, Arizona, United States

Banner Health

Phoenix, Arizona, United States

CND Life Sciences

Scottsdale, Arizona, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Stanford Neuroscience Health Center

Palo Alto, California, United States

University of Kentucky

Lexington, Kentucky, United States

Mount Sinai

New York, New York, United States

Texas Institute for Neurological Disorders

Sherman, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 3 years