Attention-Deficit/Hyperactivity DisorderVEILLETDAHNCT02217371
Role of Circadian and Homeostatic Systems in the Regulation of Wakefulness in Adult Patients With Attention Deficit Disorder With or Without Hyperactivity
A study testing Neuropsychological tests in people with Attention-Deficit/Hyperactivity Disorder, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder
- What is being tested?
- Neuropsychological tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2014to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Neuropsychological tests
- Keywords
- ADHD Patient, Healthy subjects, Sleepiness, PSG, MWT, EEG, cognitive tests
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testsOther
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).
| Study group | Role | What they receive |
|---|---|---|
| ADHD patient | Experimental | Not described Receives: Other: Neuropsychological tests |
| Healthy volunteers | Active comparator | Not described Receives: Other: Neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of objective sleepiness
Comparison of objective sleepiness in sleepy patients with ADHD and healthy subjects during a protocol of extended wake.
Measured: at inclusion (day 0)
Secondary outcomes (4)
Theta-alpha band of EEG sleep
Time constant and asymptotic value of the spectral power of the theta-alpha band of EEG sleep
Measured: At inclusion (Day 0)
Amplitude and phase of internal temperature
Measured: At inclusion (day 0)
Score of Karolinska Sleepiness Scale (subjective measure of sleepiness)
Measured: 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
Measured: At inclusion (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study start2 Sep 2014
- Primary completionMay 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention-Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyril CHAUFTON, Md, Principal investigator, University Hospital, BordeauxAntoine BENARD, MD, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217371
- Sponsor's protocol ID
- CHUBX 2013/06
- Acronym
- VEILLETDAH
- Status last verified
- Aug 2017
- First submitted
- 5 May 2014
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Circadian and Homeostatic Systems in the Regulation of Wakefulness in Adult Patients With Attention Deficit Disorder With or Without Hyperactivity
- ClinicalTrials.gov ID
- NCT02217371
- Acronym / sponsor ID
- VEILLETDAH / CHUBX 2013/06
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Keywords
- ADHD Patient, Healthy subjects, Sleepiness, PSG, MWT, EEG, cognitive tests
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 2 Sep 2014 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD patient | Experimental | Other: Neuropsychological tests |
| Healthy volunteers | Active comparator | Other: Neuropsychological tests |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (24 listed)
- 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,
Key exclusion criteria (14 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological testsThe 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). | Other | ADHD patient, Healthy volunteers |
Primary outcome
Comparison of objective sleepiness
Time frame: at inclusion (day 0)
Comparison of objective sleepiness in sleepy patients with ADHD and healthy subjects during a protocol of extended wake.
4 secondary outcomes
Theta-alpha band of EEG sleep
Time frame: At inclusion (Day 0)
Amplitude and phase of internal temperature
Time frame: At inclusion (day 0)
Score of Karolinska Sleepiness Scale (subjective measure of sleepiness)
Time frame: At inclusion (day 0)
Results of the neuropsychological tests
Time frame: At inclusion (day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Derived from this study: PubMed 33679469Bioulac 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cyril CHAUFTON, Md principal investigator
University Hospital, Bordeaux
Antoine BENARD, MD study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological tests in people with Attention-Deficit/Hyperactivity Disorder, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of objective sleepiness (time frame: at inclusion (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02217371, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.