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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05876286
Other study ID # RC31/22/0488
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 15, 2023
Est. completion date May 31, 2025

Study information

Verified date September 2023
Source University Hospital, Toulouse
Contact Mélanie PLANTON, PhD
Phone 05 61 14 59 62
Email planton.m@chu-toulouse.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 36
Est. completion date May 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria for all participants: - 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. Exclusion Criteria for all participant: - 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. Exclusion Criteria for healthy volunteers: - Subjective cognitive and/or sleep complaint.

Study Design


Related Conditions & MeSH terms

  • Attention Deficit Disorder With Hyperactivity
  • Hyperkinesis

Intervention

Other:
Neurological examinations
Neurological, neuropsychological, polysomnography examinations and multiple sleep latency test. The protocol is divided into three visits.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in signal power (db or µV 2) in the sigma frequency bands in N2 sleep difference between 2 groups 1 day
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