Ignite Creation Date:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2025-12-29 @ 6:43 AM
Study NCT ID:
NCT05757206
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-15
First Post:
2023-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Syn-Sleep Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020187', 'term': 'REM Sleep Behavior Disorder'}], 'ancestors': [{'id': 'D020923', 'term': 'REM Sleep Parasomnias'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2023-02-17', 'studyFirstSubmitQcDate': '2023-03-03', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Advance the diagnostic utility of the Syn-One Test', 'timeFrame': '3 years', 'description': '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.'}, {'measure': 'Enhance pathological reading through digital quantitative analysis of the Syn-One Test', 'timeFrame': '3 years', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['REM Sleep Behavior Disorder (iRBD)']}, 'descriptionModule': {'briefSummary': '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.\n\nSubjects 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '80 subjects diagnosed with iRBD', 'genderDescription': 'Gender at birth', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males and females age 18-85\n2. Subjects will have repeated episodes of sleep related vocalizations and/or complex motor behaviors\n3. Sleep-related behaviors/disturbances must be documented by polysomnography to occur during REM sleep\n4. Polysomnographic recording is consistent with REM sleep without atonia\n\nExclusion Criteria:\n\n1. Subjects with MoCA \\< 19, Hoehn and Yahr score \\>/=1, contraindications to skin biopsy\n2. Diagnosis of Parkinson's disease\n3. Diagnosis of dementia of any type\n4. Diagnosis of multiple system atrophy\n5. REM sleep behaviors/disturbances secondary to another cause (e.g., narcolepsy, dementia, and Parkinson's disease)\n6. Contra-indications to skin biopsy:\n\n 1. Clinical evidence of severe vascular disease (history of ulceration, poor wound healing, and vascular claudication)\n 2. History of allergic reaction to local anesthesia for skin biopsies\n 3. Use of blood thinners (aspirin of Plavix alone is allowed)\n 4. Significantly impaired wound healing or history of scarring or keloid formation"}, 'identificationModule': {'nctId': 'NCT05757206', 'briefTitle': 'The Syn-Sleep Study', 'organization': {'class': 'OTHER', 'fullName': 'CND Life Sciences'}, 'officialTitle': 'Cutaneous Phosphorylated Alpha-Synuclein for Detection of Prodromal Synucleinopathies', 'orgStudyIdInfo': {'id': '102'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Syn-One Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participating subjects will have three small skin punch biopsies.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85286', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'MD First Research', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Health', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'CND Life Sciences', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Neuroscience Health Center', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '75092', 'city': 'Sherman', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Institute for Neurological Disorders', 'geoPoint': {'lat': 33.63566, 'lon': -96.60888}}], 'overallOfficials': [{'name': 'Todd Levine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CND Life Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CND Life Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}