NCT05876286

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

October 15, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

1.6 years

First QC Date

May 16, 2023

Last Update Submit

September 18, 2023

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

SleepMemory

Outcome Measures

Primary Outcomes (1)

  • Difference in signal power (db or μV 2) in the sigma frequency bands in N2 sleep

    difference between 2 groups

    1 day

Study Arms (2)

Attention Deficit Disorder With Hyperactivity

EXPERIMENTAL

Patients with Attention Deficit Disorder With Hyperactivity. Same examinations than control group

Other: Neurological examinations

Control

ACTIVE COMPARATOR

Healthy volunteers Same examinations than Attention Deficit Disorder With Hyperactivity group

Other: Neurological examinations

Interventions

Neurological examinationsOTHER

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

Attention Deficit Disorder With HyperactivityControl

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Subjective cognitive and/or sleep complaint.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Mélanie PLANTON, PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mélanie PLANTON, PhD

CONTACT

05 61 14 59 62planton.m@chu-toulouse.fr

Study Design

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

Study Record Dates

First Submitted

May 16, 2023

First Posted

May 25, 2023

Study Start

October 15, 2023

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

September 21, 2023

Record last verified: 2023-09