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Clinical Trials/NCT01160874
NCT01160874
Completed
Not Applicable

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

University Hospital, Bordeaux2 sites in 1 country80 target enrollmentJuly 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Attention Deficit Disorder With Hyperactivity
Sponsor
University Hospital, Bordeaux
Enrollment
80
Locations
2
Primary Endpoint
Measurement of the average sleep latency during the Maintenance Wakefulness Test
Status
Completed
Last Updated
12 years ago

Overview

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 Description

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.

Registry
clinicaltrials.gov
Start Date
July 2010
End Date
July 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Group for ADHD:
  • Patients, male or female, aged 18 to 60 years
  • Patients who met the criteria for current diagnosis of ADD / ADHD according to DSM IV-TR
  • Patients who met the criteria for diagnosis in childhood ADD / ADHD, as assessed by the scale "Conners'Adult ADHD Diagnostic Interview for DSM-IV" (CCACID) (Conners, 1997)
  • Patients with a total score ≥ 20 at the CAARS (hetero-questionnaire to 30 items) (Conners, 1997) with at least 6 items of inattention or hyperactivity subscale ≥ 2
  • Patients deprived from all psychostimulants for 72 hours
  • Having been schooled up to last year of middle school
  • Having regular hours of life 3 days before entering the study
  • Having a driver's license
  • Registered Social Security

Exclusion Criteria

  • Posted or Night worker,
  • Any evolutionary neurological disorders (brain tumour, epilepsy, migraine, brain vascular accident, multiple sclerosis, myoclonus, chorea, neuropathy, muscular dystrophies, myotonic dystrophy),
  • Psychiatric comorbidity: current major depressive episode, current hypo obsessive or obsessive episode, schizophrenia,
  • Renal Disorders (renal insufficiency, nephrolithiases),
  • Endocrine Pathologies (dysthyroid, diabetes),
  • Drug addiction
  • Alcoholic Dependence during the last 6 months,
  • Dependence in the tetra-hydroxy-cannabinol
  • Long-term Treatment by benzodiazépines
  • Treatment by atomoxétine

Outcomes

Primary Outcomes

Measurement of the average sleep latency during the Maintenance Wakefulness Test

Time Frame: Day 7

Secondary Outcomes

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

Study Sites (2)

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