Sleepiness and Driving Performances in Adults With Attention-Deficit/ Hyperactivity Disorder (ADHD)
NCT ID: NCT01160874
Last Updated: 2013-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2010-07-31
2013-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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TDA/H
Polysomnography
Sleep study monitoring
Maintenance Wakefulness Test
Sleep latency testing at 10 am, 12 am, 2 pm and 4 pm.
Neuropsychological evaluation
Neuropsychological evaluation for cognitive functions study
Driving test on a simulator
Driving simulator test during wich a camera register different parameters as the position of the vehicle.
Sleep apnea patient
Maintenance Wakefulness Test
Sleep latency testing at 10 am, 12 am, 2 pm and 4 pm.
Driving test on a simulator
Driving simulator test during wich a camera register different parameters as the position of the vehicle.
Healthy volunteer
Polysomnography
Sleep study monitoring
Maintenance Wakefulness Test
Sleep latency testing at 10 am, 12 am, 2 pm and 4 pm.
Neuropsychological evaluation
Neuropsychological evaluation for cognitive functions study
Driving test on a simulator
Driving simulator test during wich a camera register different parameters as the position of the vehicle.
Interventions
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Polysomnography
Sleep study monitoring
Maintenance Wakefulness Test
Sleep latency testing at 10 am, 12 am, 2 pm and 4 pm.
Neuropsychological evaluation
Neuropsychological evaluation for cognitive functions study
Driving test on a simulator
Driving simulator test during wich a camera register different parameters as the position of the vehicle.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Anouck AMESTOY, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital Bordeaux (France)
Locations
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CHU de Bordeaux
Bordeaux, , France
Hôpital Charles Perrens
Bordeaux, , France
Countries
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References
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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.
Other Identifiers
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CHUBX 2009/17
Identifier Type: -
Identifier Source: org_study_id