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 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

REM Sleep Behavior Disorder (iRBD) Mental Disorders Nervous System Diseases Parasomnias REM Sleep Behavior Disorder REM Sleep Parasomnias Sleep Wake Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

MD First Research, Chandler, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Syn-One Test

Diagnostic Test

Participating subjects will have three small skin punch biopsies.

Primary outcomes

Advance the diagnostic utility of the Syn-One Test

Time frame: 3 years

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

Time frame: 3 years

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.

Sponsors and collaborators

Lead sponsor

CND Life Sciences

Other

Registry information

Official study title

Cutaneous Phosphorylated Alpha-Synuclein for Detection of Prodromal Synucleinopathies

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2025
First posted: Mar 7, 2023
Registry last updated: Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting