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

Primary Purpose

Attention-Deficit/Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuropsychological tests
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Attention-Deficit/Hyperactivity Disorder focused on measuring ADHD Patient, Healthy subjects, Sleepiness, PSG, MWT, EEG, cognitive tests

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ADHD patient

Healthy volunteers

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Theta-alpha band of EEG sleep
Time constant and asymptotic value of the spectral power of the theta-alpha band of EEG sleep
Amplitude and phase of internal temperature
Score of Karolinska Sleepiness Scale (subjective measure of sleepiness)
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

Full Information

First Posted
May 5, 2014
Last Updated
August 8, 2017
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT02217371
Brief Title
Role of Circadian and Homeostatic Systems in the Regulation of Wakefulness in Adult Patients With Attention Deficit Disorder With or Without Hyperactivity
Acronym
VEILLETDAH
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2, 2014 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-Deficit/Hyperactivity Disorder
Keywords
ADHD Patient, Healthy subjects, Sleepiness, PSG, MWT, EEG, cognitive tests

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADHD patient
Arm Type
Experimental
Arm Title
Healthy volunteers
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Neuropsychological tests
Intervention Description
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).
Primary Outcome Measure Information:
Title
Comparison of objective sleepiness
Description
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 Outcome Measure Information:
Title
Theta-alpha band of EEG sleep
Description
Time constant and asymptotic value of the spectral power of the theta-alpha band of EEG sleep
Time Frame
At inclusion (Day 0)
Title
Amplitude and phase of internal temperature
Time Frame
At inclusion (day 0)
Title
Score of Karolinska Sleepiness Scale (subjective measure of sleepiness)
Time Frame
At inclusion (day 0)
Title
Results of the neuropsychological tests
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cyril CHAUFTON, Md
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antoine BENARD, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33679469
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.
Results Reference
derived

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

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