Attention Deficit Disorder With HyperactivityHYPNOSNCT05876286
Sleep and Memory Consolidation in Adults With Attention Deficit Hyperactivity.
A study testing Neurological examinations in people with Attention Deficit Disorder With Hyperactivity, run by University Hospital, Toulouse.
Trial summary
Attention Deficit Disorder With Hyperactivity is associated with deficits in cognition and sleep. In healthy adults, memory consolidation processes are related to sleep spindle activity in the sleep electroencephalogram. This association is poorly characterized in adults with attention deficit hyperactivity. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Neurological examinations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2023to 31 May 2025
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age from 18 to 45 years old
- Affiliated to the French health care system
- Inclusion Criteria for attention deficit hyperactivity disorder patients:
- meeting Diagnostic and Statistical Manual (DSM)-5 criteria for mixed attention deficit hyperactivity disorder presentation without drug treatment for attention deficit hyperactivity disorder.
Who cannot join
- People not able to give consent, neurological disease (other than neurodevelopmental disorders; or any other serious disease (cancer, addiction, systemic disease)), untreated sleep apnea, major depression (Beck inventory > 15), untreated restless leg syndrome; pregnancy in progress or wish to become pregnant during the study or breastfeeding woman, drug treatment including benzodiazepine, neuroleptic or antidepressant before inclusion.
- Subjective cognitive and/or sleep complaint.
Trial locations and contacts
No sites are listed yet.
About this study
Attention Deficit Disorder With Hyperactivity is associated with deficits in cognition and sleep. In healthy adults, memory consolidation processes are related to sleep spindle activity in the sleep electroencephalogram. This association is poorly characterized in adults with attention deficit hyperactivity. In this study, the purpose is to characterize sleep microarchitecture disorders through the analysis of different stage of sleep EEG activity during a polysomnographic examination in adult with mixed Attention Deficit Disorder With Hyperactivity presentation compared to healthy.
- Being tested
- Neurological examinations
- Keywords
- Sleep, Memory
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurological examinationsOther
Neurological, neuropsychological, polysomnography examinations and multiple sleep latency test. The protocol is divided into three visits.
| Study group | Role | What they receive |
|---|---|---|
| Attention Deficit Disorder With Hyperactivity | Experimental | Patients with Attention Deficit Disorder With Hyperactivity. Same examinations than control group Receives: Other: Neurological examinations |
| Control | Active comparator | Healthy volunteers Same examinations than Attention Deficit Disorder With Hyperactivity group Receives: Other: Neurological examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in signal power (db or μV 2) in the sigma frequency bands in N2 sleep
difference between 2 groups
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start15 Oct 2023 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mélanie PLANTON, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876286
- Sponsor's protocol ID
- RC31/22/0488
- Acronym
- HYPNOS
- Status last verified
- Sep 2023
- First submitted
- 16 May 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Memory Consolidation in Adults With Attention Deficit Hyperactivity.
- ClinicalTrials.gov ID
- NCT05876286
- Acronym / sponsor ID
- HYPNOS / RC31/22/0488
- Keywords
- Sleep, Memory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 15 Oct 2023 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 25 May 2023 (actual)
- 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.
Attention Deficit Disorder With Hyperactivity is associated with deficits in cognition and sleep. In healthy adults, memory consolidation processes are related to sleep spindle activity in the sleep electroencephalogram. This association is poorly characterized in adults with attention deficit hyperactivity. In this study, the purpose is to characterize sleep microarchitecture disorders through the analysis of different stage of sleep EEG activity during a polysomnographic examination in adult with mixed Attention Deficit Disorder With Hyperactivity presentation compared to healthy.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Deficit Disorder With Hyperactivity | Experimental | Other: Neurological examinationsPatients with Attention Deficit Disorder With Hyperactivity. Same examinations than control group |
| Control | Active comparator | Other: Neurological examinationsHealthy volunteers Same examinations than Attention Deficit Disorder With Hyperactivity group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age from 18 to 45 years old
- Affiliated to the French health care system
- meeting Diagnostic and Statistical Manual (DSM)-5 criteria for mixed attention deficit hyperactivity disorder presentation without drug treatment for attention deficit hyperactivity disorder.
Key exclusion criteria (2 listed)
- People not able to give consent, neurological disease (other than neurodevelopmental disorders; or any other serious disease (cancer, addiction, systemic disease)), untreated sleep apnea, major depression (Beck inventory > 15), untreated restless leg syndrome; pregnancy in progress or wish to become pregnant during the study or breastfeeding woman, drug treatment including benzodiazepine, neuroleptic or antidepressant before inclusion.
- Subjective cognitive and/or sleep complaint.
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 |
|---|---|---|
| Neurological examinationsNeurological, neuropsychological, polysomnography examinations and multiple sleep latency test. The protocol is divided into three visits. | Other | Attention Deficit Disorder With Hyperactivity, Control |
Primary outcome
Difference in signal power (db or μV 2) in the sigma frequency bands in N2 sleep
Time frame: 1 day
difference between 2 groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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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.
Mélanie PLANTON, PhD principal investigator
University Hospital, Toulouse
Questions about this trial
What is this clinical trial studying?
A study testing Neurological examinations in people with Attention Deficit Disorder With Hyperactivity, run by University Hospital, Toulouse.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mélanie PLANTON, PhD (05 61 14 59 62 ext. 33, planton.m@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in signal power (db or μV 2) in the sigma frequency bands in N2 sleep (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2023.