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

Attention Deficit Disorder With Hyperactivity Clinical Trial

— SOMTDA/H  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01160874
• Other study ID #: CHUBX 2009/17
• Status: Completed
• Phase: N/A
• First received: July 9, 2010
• Last updated: October 24, 2013
• Start date: July 2010
• Est. completion date: July 2013

Study information

• Verified date: October 2013
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Other:
• Polysomnography
Sleep study monitoring
• 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.

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	Hôpital Charles Perrens	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of the average sleep latency during the Maintenance Wakefulness Test		Day 7	No
Secondary	The number of line crossing on the driving simulator test		Day 7	No
Secondary	Standard deviation of the average position of the vehicle in the driving simulator test		Day 7	No
Secondary	Score on Epworth Sleepiness scale		Day 7	No
Secondary	Reaction time and the percentage of error in the cognitive tests		Day 7	No