Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2025-12-26 @ 3:59 PM
NCT ID:
NCT05757206
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05757206
Study Brief:
Protocol Section:
NCT05757206