Status:
COMPLETED
Role of Circadian and Homeostatic Systems in the Regulation of Wakefulness in Adult Patients With Attention Deficit Disorder With or Without Hyperactivity
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Attention-Deficit/Hyperactivity Disorder
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
In a previous protocol, we highlighted an excessive daytime sleepiness at the Maintenance of Wakefulness Tests (MWT) in 36% of adult Attention Deficit Disorder with or without Hyperactivity (ADHD) pat...
Eligibility Criteria
Inclusion
- For ADHD patient:
- Patients male or feminine, from 18 to 50 years old,
- Patient respondent in the criterion current diagnosis of the ADHD according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) IV-TR,
- Meeting the criteria diagnosis of ADHD in the childhood, estimated by the interview " Conners'Adult ADHD Diagnostic Interview for DSM-IV " (CAADID),
- Patient presenting a total score ≥ 20 at CAARS With at least 6 items of money scales inattention or hyperactivity ≥ 2,
- Patients deprived of any psychostimulants for 72 hours,
- Presenting at the polygraphy the absence of night-respiratory disorders (AHI \< 10 / hour) and of Periodic Limbs Movements (PLMI \< 15 / hour), as well as the absence of restless legs syndrome at the interview,
- Presenting to the MWT an excessive daytime sleepiness: mean latency \< 20 min,
- Absence of syndrome of phase delay according to the criteria of l'ICSD2 (International Classification Sleep Disorders),
- Having been schooled until class of 3rd,
- Having regular schedules of life 4 days before going into the study,
- Beneficiary of a national insurance scheme,
- Having given in writing their informed consent to participate in the study.
- For healthy subject:
- Patients male or feminine, from 18 to 50 years old,
- Subjects not symptomatic of ADHD (Total score at the Wender Utah Rating Scale strictly lower than 46 on 25 questions concerning the ADHD, and less than four crosses in the more darker cases of first 6 questions of ASRS),
- Subjects not presenting complaints of sleep, nor excessive daytime sleepiness (No item equal to 4 or 5 at Basic Nordic Sleep Questionnaire (BNSQ), excepted items 16 and 17 and total score at the Epworth Sleepiness Scale \< 11),
- Presenting at the polygraphy the absence of night-respiratory disorders (AHI \< 10 / hour) and of Periodic Limbs Movements (PLMI \< 15 / hour), as well as the absence of restless legs syndromeat the interview,
- Not presenting to the MWT an excessive daytime sleepiness: mean latency \> 34 min,
- Absence of syndrome of phase delay according to the criteria of l'ICSD2 (International Classification Sleep Disorders),
- Having been schooled until class of 3rd,
- Having regular schedules of life 4 days before going into the study,
- Beneficiary of a national insurance scheme,
- Having given in writing their informed consent to participate in the study.
Exclusion
- Posted or night work,
- Any evolutionary affection (Brain tumour, epilepsy, migraine, cerebral vascular accident, calcifies, myoclonia, chorea, neuropathy, muscular dystrophies, dystrophy myotonic…),
- Psychiatric comorbidity: Current major depressive episode, current hypo obsessive or obsessive episode, schizophrenia,
- Renal disorders (Renal insufficiency, nephrolithiasis...),
- Endocrine pathologies (dysthyroidism, diabetes),
- Drug addiction during the last 6 months,
- Alcohol addiction during the last 6 months,
- Dependence in the tetra-hydroxy-cannabinol during the last 6 months,
- Long-term treatment by benzodiazepines,
- Treatment by atomoxetine,
- Pregnant and breast-feeding women,
- People under supervision, guardianship,
- Person incapable to give personally its consent,
- Nobody in emergency situation.
Key Trial Info
Start Date :
September 2 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT02217371
Start Date
September 2 2014
End Date
August 1 2017
Last Update
August 10 2017
Active Locations (1)
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1
CHU de Bordeaux
Bordeaux, France, 33000