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

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.

Study Overview

• Status: Completed
• Conditions: Attention-Deficit/Hyperactivity Disorder
• Intervention / Treatment: Other: Neuropsychological tests

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADHD patient	Other: Neuropsychological 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).
Active Comparator: Healthy volunteers	Other: Neuropsychological 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of objective sleepiness	Comparison of objective sleepiness in sleepy patients with ADHD and healthy subjects during a protocol of extended wake.	at inclusion (day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Theta-alpha band of EEG sleep	Time constant and asymptotic value of the spectral power of the theta-alpha band of EEG sleep	At inclusion (Day 0)
Amplitude and phase of internal temperature		At inclusion (day 0)
Score of Karolinska Sleepiness Scale (subjective measure of sleepiness)		At inclusion (day 0)
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	At inclusion (day 0)

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Cyril CHAUFTON, Md, University Hospital, Bordeaux; Study Chair: Antoine BENARD, MD, University Hospital, Bordeaux

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2014
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: May 5, 2014
• First Submitted That Met QC Criteria: August 13, 2014
• First Posted (Estimate): August 15, 2014

Study Record Updates

• Last Update Posted (Actual): August 10, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Healthy subjects; EEG; ADHD Patient; Sleepiness; PSG; MWT; cognitive tests
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: CHUBX 2013/06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No