The Syn-Sleep Study

Last updated: January 13, 2025
Sponsor: CND Life Sciences
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Sleep Disorders

Treatment

Syn-One Test

Clinical Study ID

NCT05757206
102
  • Ages 18-85
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Males and females age 18-85

  2. Subjects will have repeated episodes of sleep related vocalizations and/or complexmotor behaviors

  3. Sleep-related behaviors/disturbances must be documented by polysomnography to occurduring REM sleep

  4. Polysomnographic recording is consistent with REM sleep without atonia

Exclusion

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:

  7. Clinical evidence of severe vascular disease (history of ulceration, poor woundhealing, and vascular claudication)

  8. History of allergic reaction to local anesthesia for skin biopsies

  9. Use of blood thinners (aspirin of Plavix alone is allowed)

  10. Significantly impaired wound healing or history of scarring or keloid formation

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Syn-One Test
Phase:
Study Start date:
September 15, 2022
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • MD First Research

    Chandler, Arizona 85286
    United States

    Site Not Available

  • Banner Health

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • CND Life Sciences

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Stanford Neuroscience Health Center

    Palo Alto, California 94304
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Mount Sinai

    New York, New York 10003
    United States

    Site Not Available

  • Texas Institute for Neurological Disorders

    Sherman, Texas 75092
    United States

    Site Not Available

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