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

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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Disorder With Hyperactivity
• Intervention / Treatment: Other: Polysomnography; Other: Maintenance Wakefulness Test; Behavioral: Neuropsychological evaluation; Other: Driving test on a simulator

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Chu de Bordeaux
  • Bordeaux, France, 33076
    • Hôpital Charles Perrens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TDA/H	Other: Polysomnography; Sleep study monitoring; Other: Maintenance Wakefulness Test; Sleep latency testing at 10 am, 12 am, 2 pm and 4 pm.; Behavioral: Neuropsychological evaluation; Neuropsychological evaluation for cognitive functions study; Other: Driving test on a simulator; Driving simulator test during wich a camera register different parameters as the position of the vehicle.
OTHER: Sleep apnea patient	Other: Maintenance Wakefulness Test; Sleep latency testing at 10 am, 12 am, 2 pm and 4 pm.; Other: Driving test on a simulator; Driving simulator test during wich a camera register different parameters as the position of the vehicle.
OTHER: Healthy volunteer	Other: Polysomnography; Sleep study monitoring; Other: Maintenance Wakefulness Test; Sleep latency testing at 10 am, 12 am, 2 pm and 4 pm.; Behavioral: Neuropsychological evaluation; Neuropsychological evaluation for cognitive functions study; Other: Driving test on a simulator; Driving simulator test during wich a camera register different parameters as the position of the vehicle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measurement of the average sleep latency during the Maintenance Wakefulness Test	Day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Reaction time and the percentage of error in the cognitive tests	Day 7

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Anouck AMESTOY, Dr, University Hospital Bordeaux (France)

Publications and helpful links

General Publications

• Bioulac S, Chaufton C, Taillard J, Claret A, Sagaspe P, Fabrigoule C, Bouvard MP, Philip P. Excessive daytime sleepiness in adult patients with ADHD as measured by the Maintenance of Wakefulness Test, an electrophysiologic measure. J Clin Psychiatry. 2015 Jul;76(7):943-8. doi: 10.4088/JCP.14m09087.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: July 9, 2010
• First Submitted That Met QC Criteria: July 9, 2010
• First Posted (ESTIMATE): July 12, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 25, 2013
• Last Update Submitted That Met QC Criteria: October 24, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Driving; Cognition; Sleepiness; Attention Deficit Disorder / Hyperactivity (ADHD)
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Disease; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Sleepiness
• Other Study ID Numbers: CHUBX 2009/17