Sleep and Memory Consolidation in Adults With Attention Deficit Hyperactivity. (HYPNOS)

September 18, 2023 updated by: University Hospital, Toulouse
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in signal power (db or μV 2) in the sigma frequency bands in N2 sleep
Time Frame: 1 day
difference between 2 groups
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 15, 2023

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/22/0488

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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