Attention Deficit Disorder With HyperactivitySOMTDA/HNCT01160874
Sleepiness and Driving Performances in Adults With Attention-Deficit/ Hyperactivity Disorder (ADHD)
A study testing Polysomnography, Maintenance Wakefulness Test and Neuropsychological evaluation in people with Attention Deficit Disorder With Hyperactivity, run by University Hospital, Bordeaux at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Polysomnography, Maintenance Wakefulness Test and Neuropsychological evaluation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2010to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Bordeaux
Bordeaux, 33076
Hôpital Charles Perrens
Bordeaux, 33076
About this study
Official title: Sleepiness and Performances Degradation in Adults Presenting an Attention-Deficit/ Hyperactivity Disorder (ADHD)
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.
Read the 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.
- Being tested
- Polysomnography, Maintenance Wakefulness Test, Neuropsychological evaluation, Driving test on a simulator
- Keywords
- Attention Deficit Disorder / Hyperactivity (ADHD), Cognition, Sleepiness, Driving
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Spasm, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyOther
Sleep study monitoring
Maintenance Wakefulness TestOther
Sleep latency testing at 10 am, 12 am, 2 pm and 4 pm.
Neuropsychological evaluationBehavioural
Neuropsychological evaluation for cognitive functions study
Driving test on a simulatorOther
Driving simulator test during wich a camera register different parameters as the position of the vehicle.
| Study group | Role | What they receive |
|---|---|---|
| TDA/H | Experimental | Not described Receives: Other: Polysomnography; Other: Maintenance Wakefulness Test; Behavioral: Neuropsychological evaluation; Other: Driving test on a simulator |
| Sleep apnea patient | Other | Not described Receives: Other: Maintenance Wakefulness Test; Other: Driving test on a simulator |
| Healthy volunteer | Other | Not described Receives: Other: Polysomnography; Other: Maintenance Wakefulness Test; Behavioral: Neuropsychological evaluation; Other: Driving test on a simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the average sleep latency during the Maintenance Wakefulness Test
Measured: Day 7
Secondary outcomes (4)
The number of line crossing on the driving simulator test
Measured: Day 7
Standard deviation of the average position of the vehicle in the driving simulator test
Measured: Day 7
Score on Epworth Sleepiness scale
Measured: Day 7
Reaction time and the percentage of error in the cognitive tests
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anouck AMESTOY, Dr, Principal investigator, University Hospital Bordeaux (France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160874
- Sponsor's protocol ID
- CHUBX 2009/17
- Acronym
- SOMTDA/H
- Status last verified
- Oct 2013
- First submitted
- 9 Jul 2010
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25610980
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleepiness and Performances Degradation in Adults Presenting an Attention-Deficit/ Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT01160874
- Acronym / sponsor ID
- SOMTDA/H / CHUBX 2009/17
- Keywords
- Attention Deficit Disorder / Hyperactivity (ADHD), Cognition, Sleepiness, Driving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 12 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (33 listed)
- 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
Key exclusion criteria (11 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolysomnographySleep study monitoring | Other | Healthy volunteer, TDA/H |
| Maintenance Wakefulness TestSleep latency testing at 10 am, 12 am, 2 pm and 4 pm. | Other | Healthy volunteer, Sleep apnea patient, TDA/H |
| Neuropsychological evaluationNeuropsychological evaluation for cognitive functions study | Behavioural | Healthy volunteer, TDA/H |
| Driving test on a simulatorDriving simulator test during wich a camera register different parameters as the position of the vehicle. | Other | Healthy volunteer, Sleep apnea patient, TDA/H |
Primary outcome
Measurement of the average sleep latency during the Maintenance Wakefulness Test
Time frame: Day 7
4 secondary outcomes
The number of line crossing on the driving simulator test
Time frame: Day 7
Standard deviation of the average position of the vehicle in the driving simulator test
Time frame: Day 7
Score on Epworth Sleepiness scale
Time frame: Day 7
Reaction time and the percentage of error in the cognitive tests
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2013.
- Derived from this study: PubMed 25610980Bioulac 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anouck AMESTOY, Dr principal investigator
University Hospital Bordeaux (France)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polysomnography, Maintenance Wakefulness Test and Neuropsychological evaluation in people with Attention Deficit Disorder With Hyperactivity, run by University Hospital, Bordeaux at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the average sleep latency during the Maintenance Wakefulness Test (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01160874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2013.