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

NCT02217371 | Completed

• 1 other identifier: CHUBX 2013/06
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention-Deficit/Hyperactivity Disorder

Keywords

ADHD Patient; Healthy subjects; Sleepiness; PSG; MWT; EEG; cognitive tests

Outcome Measures

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.

  at inclusion (day 0)

Secondary Outcomes (4)

• 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

  At inclusion (day 0)

Study Arms (2)

ADHD patient

EXPERIMENTAL

Other: Neuropsychological tests

Healthy volunteers

ACTIVE COMPARATOR

Other: Neuropsychological tests

Interventions

Neuropsychological tests OTHER

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).

ADHD patient; Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33000, France

Location

Related Publications (1)

• 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.

  PMID: 33679469 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Sleepiness

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Cyril CHAUFTON, Md

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Antoine BENARD, MD

  University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: August 15, 2014
• Study Start: September 2, 2014
• Primary Completion: May 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 10, 2017

Record last verified: 2017-08

Locations

FR (1)