Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT06910605
Status:
RECRUITING
Last Update Posted:
2025-06-05
First Post:
2025-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploring Parameters of Driving Simulation in Relation to Drug Holidays in ADHD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097042', 'term': 'Treatment Interruption'}, {'id': 'C007792', 'term': 'Fumigant 93'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D001294', 'term': 'Attitude to Health'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'monocentric, within-subjects, observer-blinded cross-over trial (within-subject randomized crossover trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2025-03-14', 'studyFirstSubmitQcDate': '2025-03-27', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Significant differences in IDS between conditions D and M', 'timeFrame': '0, x, x+3 days, with x≥ 4 days', 'description': 'Primary outcome parameter IDS (Integrated Driving Score) will be calculated by summation of z-scores of typical driving parameters such as, for example, the standard deviation of lane position (SDLP), standard deviation of velocity (SDS) or number of inappropriate lane departures, ILD. IDS will be measured on day 0 (= baseline, Visit 1), on day x (with x≥4, Visit 2) and on day x+3 (Visit 3).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['driving simulation', 'driving performance', 'eye tracking', 'EEG-recording', 'stimulant treatment', 'drug holidays'], 'conditions': ['ADHD - Attention Deficit Disorder With Hyperactivity', 'Driving Simulator Performance', 'ADHD', 'Driving Behavior', 'Driving Ability']}, 'descriptionModule': {'briefSummary': 'Attention deficit hyperactivity disorder (ADHD) or syndrome (ADHS) is a symptomatically defined condition that - if untreated - is linked to a significantly increased risk of traffic accidents. In a recent umbrella review, where data from reviews and meta-analyses on 21.142.129 adults was assessed, a pooled prevalence of 3.1% of ADHD in adults was estimated. Considering that globally around 1.35 million people lose their lives and more than 50 million are suffering from injuries or disabilities due to road accidents, the fraction of car accidents caused by ADHD as a risk factor is considerable and needs to be addressed. This risk is largely presumed to be caused by an elevated level of inattentiveness in affected persons.\n\nCompounds of different groups, which can be classified in stimulants - formulations of methylphenidate and amphetamine - and non-stimulants - atomoxetin, guanfacine and clonidine -, have been shown to be effective in alleviating negative effects of ADHD, including inattentiveness. Under well-established but individually managed medication regimes, affected individuals can consequently lead a largely "unirritated" life and are not subject to fundamental restriction with respect to driving anymore.\n\nIn children and adolescents, documented negative effects of stimulant medication include loss of appetite and decreased growth rates. It could however be shown that short-term interruptions (weekend, school holidays, and alike), introduced to alleviate aforementioned effects, do not affect the drug\'s beneficial effects in functional use (e.g., school). Such monitored medication breaks are often called "drug holidays" (D). They have become standard procedure in well-monitored treatment, predominantly including behavioral therapy.\n\nBased on own experience in childhood and or hearsay, also a fraction of affected adults under stimulant medication expresses the desire to take drug holidays and "be themselves" from time to time. With the predominant fraction of medication being fast acting drugs in extended-release formulation and typical patients being not only highly compliant but also extremely informed and adherent, these so-called "drug holidays" are reported an accepted in therapeutically accompanied settings of adults by now.\n\nHowever, while the overall positive effect of stimulant treatment on driving performance has been confirmed in a row of excellent on road- and/or simulation studies using integrated driving scores (IDS), so far there is no study available addressing the effect of drug holidays in adult drivers on driving performance. This represents a significant gap of evidence for both medical experts and affected.\n\nThe proposed study will address this gap by exploring parameters of driving simulation in relation to drug holidays in ADHD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* adult drivers\n* ADHD-diagnosed, established ADHD-treatment only with stimulants\n* known history of drug holidays based on own decision,\n* at impaired eyesight with more than +/- 5 diopter or astigmatism\n* contact lenses are required (for eye tracking)\n\nExclusion criteria:\n\n* sensibility to motion sickness (kinetosis, dizziness etc. in 5 min screening drive)\n* non-stimulant-treatment\n* inability to understand the study procedure for linguistic or cognitive reasons\n* professional drivers (if working during the study period)\n* for women: pregnancy'}, 'identificationModule': {'nctId': 'NCT06910605', 'acronym': 'DS-ADHD1', 'briefTitle': 'Exploring Parameters of Driving Simulation in Relation to Drug Holidays in ADHD Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Exploring Parameters of Driving Simulation in Relation to Drug Holidays in ADHD Patients', 'orgStudyIdInfo': {'id': 'DS-ADHD1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: M-M-D', 'description': 'stimulant-treated ADHD-affected participants will perform test sequence first in medicated state (M), then again in medicated state (M), then during "drug holidays" (D).', 'interventionNames': ['Drug: "drug holidays" (D)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: M-D-M', 'description': 'stimulant-treated ADHD-affected participants will perform test sequence first in medicated state (M), then during "drug holidays" (D), then again in medicated state (M).', 'interventionNames': ['Drug: "drug holidays" (D)']}], 'interventions': [{'name': '"drug holidays" (D)', 'type': 'DRUG', 'description': 'Participants omit three consecutive daily doses of ADHD-medication (stimulant).', 'armGroupLabels': ['Group 1: M-M-D', 'Group 2: M-D-M']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8050', 'city': 'Zurich', 'state': 'ZRH', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Stefan Lakämper, Dr. rer. nat.', 'role': 'CONTACT', 'email': 'stefan.lakaemper@irm.uzh.ch', 'phone': '+41793789984'}, {'name': 'Nan Li, MSc', 'role': 'CONTACT', 'email': 'nan.li@irm.uzh.ch'}], 'facility': 'Division of Traffic Medicine, Institute of Forensic Medicine, University of Zurich,', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Stefan Lakämper, Dr. rer. nat.', 'role': 'CONTACT', 'email': 'stefan.lakaemper@irm.uzh.ch', 'phone': '+41793789984'}, {'name': 'Nan Li, MSc', 'role': 'CONTACT', 'email': 'nan.li@irm.uzh.ch', 'phone': '+41797283245'}], 'overallOfficials': [{'name': 'Stefan Lakämper, Dr. rer. nat.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}, {'name': 'Kristina Keller, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'starting after publication of study protcol and/or results', 'ipdSharing': 'YES', 'description': 'Results will be published in peer-reviewed journals. Anonymized raw data will be made available upon request.', 'accessCriteria': 'upon request by mail'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stefan Lakämper', 'class': 'OTHER'}, 'collaborators': [{'name': 'Psychiatric University Hospital, Zurich', 'class': 'OTHER'}, {'name': 'Swiss Federal Institute of Technology in Zurich (ETHZ)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr. rer. nat. , Head Research & Research Development, Division of TRaffic Medicine, Institute for Forensic Medicine, University of Zurich', 'investigatorFullName': 'Stefan Lakämper', 'investigatorAffiliation': 'University of Zurich'}}}}