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CompletedNCT02217371VEILLETDAHUpdated Aug 10, 2017

Role of Circadian and Homeostatic Systems in the Regulation of Wakefulness in Adult Patients With Attention Deficit Disorder With or Without Hyperactivity

An interventional study of Neuropsychological tests in Attention-Deficit/Hyperactivity Disorder, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-10.

Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Attention-Deficit/Hyperactivity Disorder

Keywords

  • ADHD Patient
  • Healthy subjects
  • Sleepiness
  • PSG
  • MWT
  • EEG
  • cognitive tests
03

In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's enrollment of 19 is below the median of 80 across 583 interventional studies indexed under Hyperkinesis.

Browse Hyperkinesis studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    ADHD patient

    Other: Neuropsychological tests

  • Active comparator
    Healthy volunteers

    Other: Neuropsychological tests

Interventions

  • OtherNeuropsychological tests

    The tests are : Go/NoGo paradigm, Continuous Performance Test (CPT) II , Wisconsin Card Sorting Test (WCST), virtual CPT, Classic and virtual Stroop, PSG, MWT These tests will be repeated during 32h each 4h (T0h, T4h, T8h, T12h, T16h, T20h, T24h, T28h et T32h).

06

What researchers measure

Primary outcomes

  1. Comparison of objective sleepiness

    Comparison of objective sleepiness in sleepy patients with ADHD and healthy subjects during a protocol of extended wake.

    Time frame: at inclusion (day 0)

Secondary outcomes

  1. Theta-alpha band of EEG sleep

    Time constant and asymptotic value of the spectral power of the theta-alpha band of EEG sleep

    Time frame: At inclusion (Day 0)

  2. Amplitude and phase of internal temperature

    Time frame: At inclusion (day 0)

  3. Score of Karolinska Sleepiness Scale (subjective measure of sleepiness)

    Time frame: At inclusion (day 0)

  4. Results of the neuropsychological tests

    * Go/NoGO paradigm * Continuous Performance Test and virtual Continuous Performance Test * Stroop test and virtual stroop test * Wisconsin Card Sorting Test

    Time frame: At inclusion (day 0)

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Study locations

1 site
  • CHU de Bordeaux
    Bordeaux, 33000, France
08

References and documents

Publications

  • 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. PubMed 33679469 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02217371
Lead sponsor
University Hospital, Bordeaux
Responsible party
Sponsor
First posted
Aug 15, 2014
Start date
Sep 2, 2014
Primary completion
May 2017
Completion
Aug 2017
Last update
Aug 10, 2017

Study contacts

Cyril CHAUFTON, Md
principal investigator · University Hospital, Bordeaux
Antoine BENARD, MD
study chair · University Hospital, Bordeaux

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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