Clinical Trial: Sleepiness and Driving Performances in Adults With Attention-Deficit/ Hyperactivity Disorder (ADHD)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Sleepiness and Performances Degradation in Adults Presenting an Attention-Deficit/ Hyperactivity Disorder (ADHD)

Brief Summary: The Attention Deficit/ Hyperactivity Disorder (ADHD) is a developmental disorder which affects 3 to 5 % of school age children. This disorder persists in the adulthood for 60 % of subjects. Children with ADHD are sleepier during the day than normal children. However, there is no information concerning the diurnal sleepiness of adults with ADHD and the impact of this sleepiness on their driving capacity. The investigators postulate that the negative impact of ADHD is due to an awakening disorder which adds to the attentional disorder. The aim of this study is to estimate both the sleepiness by a Maintenance Wakefulness Test (MWT) and the capacity to drive in adults with ADHD.

Detailed Summary:

The main objective of this study is to estimate both the sleepiness by a Maintenance Wakefulness Test (MWT) and the capacity to drive in adults presenting an ADHD. Duration of participation for each patients will be 7 days. Four days after inclusion, patients will have to stop all psychostimulant treatment. Participants will then spend 24 hours (on days 6 and 7) at the "Groupe d'Etudes Neurophysiologie Pharmacologie Sommeil et Sommnolence"(GENPPHASS) in the "Centre Hospitalier Universitaire"(CHU) of Bordeaux. During this time, they will undergo complete polysomnography.The next day, they will perform a Maintenance Wakefulness Test (MWT). A neuropsychological evaluation of one hour will also be done. Finally, a driving test on a simulator will be performed.

Study significance: patients will benefit from an objective exploration of their sleep (with possibly, a sleep disorder discovery) and from a specific treatment. This study will demonstrate the necessity to investigate daytime function (sleepiness and performance) and the sleep quality of patients with ADHD. It will also demonstrate that part of the adults with ADHD handicap is based on an awakening disorder which adds to the attentional disorder.


Sponsor: University Hospital, Bordeaux

Current Primary Outcome: Measurement of the average sleep latency during the Maintenance Wakefulness Test [ Time Frame: Day 7 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The number of line crossing on the driving simulator test [ Time Frame: Day 7 ]
  • Standard deviation of the average position of the vehicle in the driving simulator test [ Time Frame: Day 7 ]
  • Score on Epworth Sleepiness scale [ Time Frame: Day 7 ]
  • Reaction time and the percentage of error in the cognitive tests [ Time Frame: Day 7 ]


Original Secondary Outcome:

  • The number of line crossing on the driving simulator test [ Time Frame: Day 7 ]
  • Standard deviation of the average position of the vehicule in the driving simulator test [ Time Frame: Day 7 ]
  • Score on Epworth Sleepiness scale [ Time Frame: Day 7 ]
  • Reaction time and the percentage of error in the cognitive tests [ Time Frame: Day 7 ]


Information By: University Hospital, Bordeaux

Dates:
Date Received: July 9, 2010
Date Started: July 2010
Date Completion:
Last Updated: October 24, 2013
Last Verified: October 2013