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

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Polysomnography
Maintenance Wakefulness Test
Neuropsychological evaluation
Driving test on a simulator
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Attention Deficit Disorder With Hyperactivity focused on measuring Attention Deficit Disorder / Hyperactivity (ADHD), Cognition, Sleepiness, Driving

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de Bordeaux
  • Hôpital Charles Perrens

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Other

Arm Label

TDA/H

Sleep apnea patient

Healthy volunteer

Arm Description

Outcomes

Primary Outcome Measures

Measurement of the average sleep latency during the Maintenance Wakefulness Test

Secondary Outcome Measures

The number of line crossing on the driving simulator test
Standard deviation of the average position of the vehicle in the driving simulator test
Score on Epworth Sleepiness scale
Reaction time and the percentage of error in the cognitive tests

Full Information

First Posted
July 9, 2010
Last Updated
October 24, 2013
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT01160874
Brief Title
Sleepiness and Driving Performances in Adults With Attention-Deficit/ Hyperactivity Disorder (ADHD)
Acronym
SOMTDA/H
Official Title
Sleepiness and Performances Degradation in Adults Presenting an Attention-Deficit/ Hyperactivity Disorder (ADHD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
Attention Deficit Disorder / Hyperactivity (ADHD), Cognition, Sleepiness, Driving

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TDA/H
Arm Type
Experimental
Arm Title
Sleep apnea patient
Arm Type
Other
Arm Title
Healthy volunteer
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Polysomnography
Intervention Description
Sleep study monitoring
Intervention Type
Other
Intervention Name(s)
Maintenance Wakefulness Test
Intervention Description
Sleep latency testing at 10 am, 12 am, 2 pm and 4 pm.
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological evaluation
Intervention Description
Neuropsychological evaluation for cognitive functions study
Intervention Type
Other
Intervention Name(s)
Driving test on a simulator
Intervention Description
Driving simulator test during wich a camera register different parameters as the position of the vehicle.
Primary Outcome Measure Information:
Title
Measurement of the average sleep latency during the Maintenance Wakefulness Test
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
The number of line crossing on the driving simulator test
Time Frame
Day 7
Title
Standard deviation of the average position of the vehicle in the driving simulator test
Time Frame
Day 7
Title
Score on Epworth Sleepiness scale
Time Frame
Day 7
Title
Reaction time and the percentage of error in the cognitive tests
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anouck AMESTOY, Dr
Organizational Affiliation
University Hospital Bordeaux (France)
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hôpital Charles Perrens
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25610980
Citation
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.
Results Reference
derived

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

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