search
Back to results

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

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neurological examinations
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Attention Deficit Disorder With Hyperactivity focused on measuring Sleep, Memory

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Attention Deficit Disorder With Hyperactivity

    Control

    Arm Description

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

    Healthy volunteers Same examinations than Attention Deficit Disorder With Hyperactivity group

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    May 16, 2023
    Last Updated
    September 18, 2023
    Sponsor
    University Hospital, Toulouse
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05876286
    Brief Title
    Sleep and Memory Consolidation in Adults With Attention Deficit Hyperactivity.
    Acronym
    HYPNOS
    Official Title
    Sleep and Memory Consolidation in Adults With Attention Deficit Hyperactivity.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 15, 2023 (Anticipated)
    Primary Completion Date
    May 31, 2025 (Anticipated)
    Study Completion Date
    May 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Toulouse

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Attention Deficit Disorder With Hyperactivity
    Keywords
    Sleep, Memory

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Attention Deficit Disorder With Hyperactivity
    Arm Type
    Experimental
    Arm Description
    Patients with Attention Deficit Disorder With Hyperactivity. Same examinations than control group
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Healthy volunteers Same examinations than Attention Deficit Disorder With Hyperactivity group
    Intervention Type
    Other
    Intervention Name(s)
    Neurological examinations
    Intervention Description
    Neurological, neuropsychological, polysomnography examinations and multiple sleep latency test. The protocol is divided into three visits.
    Primary Outcome Measure Information:
    Title
    Difference in signal power (db or μV 2) in the sigma frequency bands in N2 sleep
    Description
    difference between 2 groups
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mélanie PLANTON, PhD
    Phone
    05 61 14 59 62
    Ext
    33
    Email
    planton.m@chu-toulouse.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mélanie PLANTON, PhD
    Organizational Affiliation
    University Hospital, Toulouse
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Sleep and Memory Consolidation in Adults With Attention Deficit Hyperactivity.

    We'll reach out to this number within 24 hrs