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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01160874
First received: July 9, 2010
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Attention Deficit Disorder With Hyperactivity
Other: Polysomnography
Other: Maintenance Wakefulness Test
Behavioral: Neuropsychological evaluation
Other: Driving test on a simulator

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Sleepiness and Performances Degradation in Adults Presenting an Attention-Deficit/ Hyperactivity Disorder (ADHD)

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Measurement of the average sleep latency during the Maintenance Wakefulness Test [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of line crossing on the driving simulator test [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Standard deviation of the average position of the vehicle in the driving simulator test [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Score on Epworth Sleepiness scale [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Reaction time and the percentage of error in the cognitive tests [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: July 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160874

Locations
France
CHU de Bordeaux
Bordeaux, France, 33076
Hôpital Charles Perrens
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Anouck AMESTOY, Dr University Hospital Bordeaux (France)
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01160874     History of Changes
Other Study ID Numbers: CHUBX 2009/17
Study First Received: July 9, 2010
Last Updated: October 24, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Attention Deficit Disorder / Hyperactivity (ADHD)
Cognition
Sleepiness
Driving

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 01, 2014