Clinical trial NCT02217371: Role of Circadian and Homeostatic Systems in the Regulation of Wakefulness in Adult Patients With Attention Deficit Disorder With or Without Hyperactivity
Official title: Role of Circadian and Homeostatic Systems in the Regulation of Wakefulness in Adult Patients With Attention Deficit Disorder With or Without Hyperactivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention-Deficit/Hyperactivity Disorder
Keywords: ADHD Patient
Healthy subjects
Sleepiness
PSG
MWT
EEG
cognitive tests
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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) patients. In 40% of cases this sleepiness was associated with a sleep disorder objectified by polysomnography (PSG): apnea hypopnea syndrome (AHI) ≥ 10/h and / or Periodicals Movements of Lower Limb (PLMI) ≥ 15/h. However, among patients with no sleep disorder PSG, we can question the central origin of the Excessive Daytime Sleepiness. Thus, we wish to determine potential changes in the regulation of sleep / wake cycle through a protocol of extended wake.

The principal objective is to compare the objective sleepiness in sleepy patients with ADHD and healthy subjects during a protocol of extended wake.

It's an observational study of interventional type realized in patient with ADHD syndrome deprived of psychostimulant treatment (for 72 hours) and healthy subject, investigating the implication of the homeostatic and circadian systems in the preservation of awakening.


Eligibility criteria: Inclusion Criteria:

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 Criteria:

* 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.

Primary outcomes:
measure: Comparison of objective sleepiness
timeFrame: at inclusion (day 0)
Secondary outcomes:
measure: Theta-alpha band of EEG sleep
timeFrame: At inclusion (Day 0)
measure: Amplitude and phase of internal temperature
timeFrame: At inclusion (day 0)
measure: Score of Karolinska Sleepiness Scale (subjective measure of sleepiness)
timeFrame: At inclusion (day 0)
measure: Results of the neuropsychological tests
timeFrame: At inclusion (day 0)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Cyril CHAUFTON, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Antoine BENARD, MD
role: STUDY_CHAIR
References:
citation: Bioulac S, Sagaspe P, Tron E, Benard A, Berthomier C, Brandewinder M, Philip P, Taillard J. Does Homeostatic Sleep Pressure Buildup Explain Objective Excessive Daytime Sleepiness in Adults With ADHD? An Exploratory Study. Front Psychiatry. 2021 Feb 19;12:586528. doi: 10.3389/fpsyt.2021.586528. eCollection 2021.