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临床试验/NCT06910605
NCT06910605招募中不适用

Exploring Parameters of Driving Simulation in Relation to Drug Holidays in ADHD Patients

Stefan Lakämper1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年6月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
26
试验地点
1
主要终点
Significant differences in IDS between conditions D and M

研究概览

简要总结

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.

Compounds 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.

In 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.

Based 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.

However, 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.

The proposed study will address this gap by exploring parameters of driving simulation in relation to drug holidays in ADHD patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
10 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Group 1: M-M-D

Experimental

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).

干预措施: "drug holidays" (D) (Drug)

Group 2: M-D-M

Experimental

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).

干预措施: "drug holidays" (D) (Drug)

结局指标

主要结局

Significant differences in IDS between conditions D and M

时间窗: 0, x, x+3 days, with x≥ 4 days

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).

次要结局

未报告次要终点

研究者

发起方
Stefan Lakämper
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Stefan Lakämper

Dr. rer. nat. , Head Research & Research Development, Division of TRaffic Medicine, Institute for Forensic Medicine, University of Zurich

University of Zurich

研究点 (1)

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