HYPNOS: Sleep and Memory Consolidation in Adults With Attention Deficit Hyperactivity

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05876286

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Disorder With Hyperactivity	Other: Neurological examinations	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Sleep and Memory Consolidation in Adults With Attention Deficit Hyperactivity

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

May 31, 2025

Anticipated Study Completion Date :

May 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Attention Deficit Disorder With Hyperactivity Patients with Attention Deficit Disorder With Hyperactivity. Same examinations than control group	Other: Neurological examinations Neurological, neuropsychological, polysomnography examinations and multiple sleep latency test. The protocol is divided into three visits.
Active Comparator: Control Healthy volunteers Same examinations than Attention Deficit Disorder With Hyperactivity group	Other: Neurological examinations Neurological, neuropsychological, polysomnography examinations and multiple sleep latency test. The protocol is divided into three visits.

Arm

Intervention/Treatment

Experimental: Attention Deficit Disorder With Hyperactivity

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

Other: Neurological examinations

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

Active Comparator: Control

Healthy volunteers Same examinations than Attention Deficit Disorder With Hyperactivity group

Other: Neurological examinations

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

Outcome Measures

Primary Outcome Measures

Difference in signal power (db or μV 2) in the sigma frequency bands in N2 sleep [1 day]
difference between 2 groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

Principal Investigator: Mélanie PLANTON, PhD, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Toulouse

ClinicalTrials.gov Identifier:

NCT05876286

Other Study ID Numbers:

RC31/22-0488

First Posted:

May 25, 2023

Last Update Posted:

May 25, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Toulouse

Sleep

Memory

Additional relevant MeSH terms:

Hyperkinesis

Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of May 25, 2023