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

NCT01160874 | Completed

• 1 other identifier: CHUBX 2009/17
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Attention Deficit Disorder / Hyperactivity (ADHD); Cognition; Sleepiness; Driving

Outcome Measures

Primary Outcomes (1)

• Measurement of the average sleep latency during the Maintenance Wakefulness Test

  Day 7

Secondary Outcomes (4)

• 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

Study Arms (3)

TDA/H

EXPERIMENTAL

Other: Polysomnography; Other: Maintenance Wakefulness Test; Behavioral: Neuropsychological evaluation; Other: Driving test on a simulator

Sleep apnea patient

OTHER

Other: Maintenance Wakefulness Test; Other: Driving test on a simulator

Healthy volunteer

OTHER

Other: Polysomnography; Other: Maintenance Wakefulness Test; Behavioral: Neuropsychological evaluation; Other: Driving test on a simulator

Interventions

Polysomnography OTHER

Sleep study monitoring

Healthy volunteer; TDA/H

Maintenance Wakefulness Test OTHER

Sleep latency testing at 10 am, 12 am, 2 pm and 4 pm.

Healthy volunteer; Sleep apnea patient; TDA/H

Neuropsychological evaluation BEHAVIORAL

Neuropsychological evaluation for cognitive functions study

Healthy volunteer; TDA/H

Driving test on a simulator OTHER

Driving simulator test during wich a camera register different parameters as the position of the vehicle.

Healthy volunteer; Sleep apnea patient; TDA/H

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (2)

CHU de Bordeaux

Bordeaux, 33076, France

Location

Hôpital Charles Perrens

Bordeaux, 33076, France

Location

Related Publications (1)

• 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.

  PMID: 25610980 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Spasm; Sleepiness

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anouck AMESTOY, Dr

  University Hospital Bordeaux (France)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2010
• First Posted: July 12, 2010
• Study Start: July 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 25, 2013

Record last verified: 2013-10

Locations

FR (2)