Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT06167369
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2023-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biological and Cognitive Marker of Neurodegeneration in Obstructive Sleep Apnea Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D009410', 'term': 'Nerve Degeneration'}, {'id': 'C537987', 'term': 'Charcot-Marie-Tooth disease, Type 1F'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum samples for measurement of neurobiological parameters like Neurofilament light chain or Glial fibrillary acidic protein'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 136}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-16', 'studyFirstSubmitDate': '2023-11-23', 'studyFirstSubmitQcDate': '2023-12-04', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of neurofilament light chain', 'timeFrame': 'From enrollment to the follow up time point after 6 months of treatment', 'description': 'longitudinal analysis'}], 'secondaryOutcomes': [{'measure': 'Concentration of Neurofilament light chain', 'timeFrame': 'From enrollment to the follow up time point after 6 months of treatment, in between the groups', 'description': 'in between the groups (assessed after 6 months)'}, {'measure': 'Concentration of Glial fibrillary acidic protein', 'timeFrame': 'From enrollment to the follow up time point after 6 months of treatment', 'description': 'longitudinal analysis and in between the groups (assessed after 6 months)'}, {'measure': 'Cognitive performance measured by SDMT, MoCA', 'timeFrame': 'From enrollment to the follow up time point after 6 months of treatment', 'description': 'Longitudinal analysis and in between the groups (assessed after 6 months)'}, {'measure': 'Objective sleep parameters measured by polysomnography or equivalent measuremt methods', 'timeFrame': 'From enrollment to the follow up time point after 6 months of treatment', 'description': 'Longitudinal analysis and in between the groups (assessed after 6 months). For example objective parameters like apnea-hypopnea-index per hour or sleep efficacy in %.'}, {'measure': 'Subjective sleep parameters measured by symptoms questionnaires (Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index)', 'timeFrame': 'From enrollment to the follow up time point after 6 months of treatment', 'description': 'Longitudinal analysis and in between the groups (assessed after 6 months). For example parameters like sleepiness (ESS-questionnnaire, min to max 0 to 24 points) or sleep quality (PSQI-questionnaire, min to max 0 to 21 points). Lower score values represent fewer symptom load.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep apnea', 'Neurodegeneration', 'Neurofilament light chain', 'Glial fibrillary acidic protein', 'Positive airway pressure therapy'], 'conditions': ['Sleep Apnea, Obstructive']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to investigate biomarkers and neurocognitive markers of neurodegenerative processes in obstructive sleep apnea patients.\n\nThe main questions the study aims to answer are:\n\n* Does neurodegeneration assessed by neurobiological markers and neurocognitive test performance exists in obstructive sleep apnea?\n* Are these neurodegenerative markers are associated with the adherence to clinical prescribed positive airway pressure therapy?\n\nNewly diagnosed patients with obstructive sleep apnea will be observed during the use of clinical prescribed positive pressure therapy. Different study related investigations take place before and six months after treatment start.\n\nResearchers will compare after six months the group of adherent treatment participants with the non-adherent treatment participants group to investigate if differences in the observed neurobiological or neurocognitive parameters exist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that are reffered to the sleep lab of the University Hospital Dresden', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* newly diagnosed obstructive sleep apnea\n* clinical indication for start of positive airwas pressure therapy\n* Age older than 18 years\n\nExclusion Criteria:\n\n* neurodegenerative disease\n* Multiple sclerosis\n* Stroke within last 3 months\n* Brain injury within last 3 months\n* MoCA \\< 21 points\n* higher degree chonic kidney disease (lower than 30 mL/min)\n* regular use of sleep pills (e.g. Zopiclon, Mirtazapin, Daridorexant)'}, 'identificationModule': {'nctId': 'NCT06167369', 'briefTitle': 'Biological and Cognitive Marker of Neurodegeneration in Obstructive Sleep Apnea Patients', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Biological and Cognitive Marker of Neurodegeneration in Obstructive Sleep Apnea Patients', 'orgStudyIdInfo': {'id': 'MeDDrive: BICONOS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Newly diagnosed sleep apnea patients, starting clinical prescribed positive airway pressure therapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Tony Sehr, MD', 'role': 'CONTACT', 'email': 'tony.sehr@ukdd.de', 'phone': '+49 351 458 0'}, {'name': 'Tony Sehr, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Moritz D Brandt, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tjalf Ziemssen, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Katja Akgün, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Technische Universität Dresden, Universitätsklinikum Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'centralContacts': [{'name': 'Tony Sehr, MD', 'role': 'CONTACT', 'email': 'tony.sehr@ukdd.de', 'phone': '+49 351 458 19324'}, {'name': 'Moritz D Brandt, MD', 'role': 'CONTACT', 'email': 'moritz.brandt@ukdd.de'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tony Sehr', 'investigatorAffiliation': 'Technische Universität Dresden'}}}}