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

Not Applicable

Completed

• Conditions: Attention Deficit Disorder With Hyperactivity
• Interventions: Other: Polysomnography; Other: Maintenance Wakefulness Test; Other: Driving test on a simulator; Behavioral: Neuropsychological evaluation

• Registration Number: NCT01160874
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-09
• Study First Submitted QC: 2010-07-09
• Study First Posted: 2010-07-12
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-24
• Last Update Posted: 2013-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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
• Having given their written informed consent to participate in the study
• Consent free, informed and written, dated and signed by the patient and the investigator before any examination required by the research.

For the apneic group:

• Patients, male or female, aged 18 to 60 years
• Patients with apnea index of apnea / hypopnea> 10
• 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
• Having given their written informed consent to participate in the study
• Consent free, informed and written, dated and signed by the patient and the investigator before any examination required by the research

For the control group:

• Participant male or female, aged 18 to 60 years
• Participant not symptomatic of ADHD (total score WURS less than 46 of the 25 questions about ADHD, and at least four more crosses in the boxes shaded the first 6 issues of ASRS)
• Participant with no complaints of sleep, or excessive daytime sleepiness (no item equal to 4 or 5 to BNSQ, except for items 16 and 17 (for snoring) and ESS total score below 11)
• Participant with an AHI <10 and MPS index <15 in ambulatory polygraph during the night of selection
• Participant with an AHI <10 and MPS Index <15 after overnight polysomnography in the laboratory prior to the day of testing
• Having been schooled until the third class,
• Having regular hours of life 3 days before entering the study,
• Having a driver's license,
• Registered Social Security,
• Having given their written informed consent to participate in the study
• Consent free, informed and written, dated and signed by the participant and the investigator before any examination required by the research.

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
• Persons placed under protection of justice

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TDA/H	Polysomnography	-
TDA/H	Maintenance Wakefulness Test	-
Sleep apnea patient	Driving test on a simulator	-
Sleep apnea patient	Maintenance Wakefulness Test	-
Healthy volunteer	Maintenance Wakefulness Test	-
Healthy volunteer	Polysomnography	-
TDA/H	Neuropsychological evaluation	-
TDA/H	Driving test on a simulator	-
Healthy volunteer	Neuropsychological evaluation	-
Healthy volunteer	Driving test on a simulator	-

Primary Outcome Measures

Name	Time	Method
Measurement of the average sleep latency during the Maintenance Wakefulness Test	Day 7

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Hôpital Charles Perrens; 🇫🇷 Bordeaux, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France