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Sleep, Rhythms and Risk of Alzheimer's Disease (AMImage3)

Primary Purpose

Alzheimer Disease, Sleep

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Multimodal brain imaging (MRI)
Actimetry
Sleep Diary
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alzheimer Disease focused on measuring Aging, Sleep/wake Cycle, Hippocampal connectivity, Hippocampal dependant Memory tests, Actigraphy, Functional and structural MRI

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Belonging to AMImage 2 cohort and preferentially belonging to subjects included in the first actimetric assessment. AMI subjects have been selected based on Mutualité Sociale Agricole of Gironde (agricultural Health Insurance system database as followed :

    • >65 years old
    • Retired from agriculture
    • Living in Gironde countryside
    • Being affiliated to the French Farmers Health Insurance
  • Signed Informed Consent

Exclusion Criteria:

  • Left Handed subjects
  • Severe dementia (MMSE<13)
  • Stroke
  • Parkinson's disease
  • MRI contraindication
  • Health state not allowing displacement to the hospital
  • Person under gardianship and not able to give its informed consent

Sites / Locations

  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sample of 100 persons included in AMI / AMImage 2

Arm Description

Sample of 100 persons included in AMI / AMImage 2

Outcomes

Primary Outcome Measures

Bold Signal
Bold Signal on Magnetic Resonance Imaging (MRI)

Secondary Outcome Measures

Pittsburgh Sleep Quality Index (PSQI) Score
seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality
Mannheim Dream questionnaire (MADRE)
MADRE questionnaire evaluates dream recall frequency, emotional aspects of dreams (intensity and tonality), nightmares, lucid dreaming, attitude towards dreams, effects of dreams on waking life and dream literature reading and has been demonstrated to show high retest reliability
Epworth Sleepiness Scale
The test is a list of eight situations in which is rate the tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing
Toronto Alexithymia Scale (TAS-20)
The TAS-20 is a self-report scale that is comprised of 20 items. The TAS-20 has 3 subscales: Difficulty Describing Feelings subscale is used to measure difficulty describing emotions. 5 items. Difficulty Identifying Feeling subscale is used to measure difficulty identifying emotions. 7 items. Externally-Oriented Thinking subscale is used to measure the tendency of individuals to focus their attention externally. 8 items. Items are rated using a 5-point Likert scale whereby 1 = strongly disagree and 5 = strongly agree. The total alexithymia score is the sum of responses to all 20 items, while the score for each subscale factor is the sum of the responses to that subscale. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 = possible alexithymia.
Positive and Negative Affective Scale (PANAS)
The PANAS Scale or Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire. The test comprises 20 terms, with ten focusing on a positive emotion and the other ten focusing on a negative emotion. The final score of the PANAS Scale / Positive and Negative Affect Schedule (PANAS) test is the sum of the 10 terms on the positive scale and the sum of the 10 terms on the negative scale. The value assigned is positive for answers on the positive scale and negative for answers on the negative scale.
Emotional Regulation Questionnaire (ERQ)
10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). The scoring takes the average of all the scores.
Actimetry
Automatically record of waking and sleeping periods on 7 consecutive days
Sleep diary
Series of questions for each 24-hour period with a collection of bedtime, wake-up time, possible night awakenings or even naps

Full Information

First Posted
July 25, 2019
Last Updated
March 30, 2022
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT04044495
Brief Title
Sleep, Rhythms and Risk of Alzheimer's Disease
Acronym
AMImage3
Official Title
"Sleep, Rhythms and Risk of Alzheimer's Disease: a Daily Life Actigraphic Assessment and MRI Study" "SoRyMA - AMImage3"
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
February 22, 2022 (Actual)
Study Completion Date
February 22, 2022 (Actual)

3. Sponsor/Collaborators

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

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
Alterations in sleep and the sleep / wake cycle, which are particularly common in Alzheimer's disease patients, could represent an early biomarker for cognitive decline and onset of dementia . Moreover, these disturbances in activity rhythms and sleep patterns represent modifiable factors and therefore potential targets for the prevention of certain neurodegenerative disorders. The main objective of this study will be to test the hypothesis that elderly people without major cognitive impairment who have circadian rhythm disorders of the sleep / wake cycle have structural and / or functional abnormalities in the central nervous system and more specifically of the hippocampal function which could represent a risk factor for the occurrence of cognitive impairment. Indeed, although many studies in both humans and animals suggest the existence of links between sleep alterations and age-related cognitive impairment, the causality of these observations is still not clear. This description of the anatomical and functional substratum of sleep / wake cycle alterations occurring in an elderly population will be based on joint analysis of multimodal brain imaging (MRI) and neuropsychology actimetry data. The SoRyMA-AMImage 3 protocol will correspond to the 2nd actimetry measurement point and the 3rd MRI measurement point of a larger population-based cohort AMImage. This project will collect data from the sleep / wake cycle (actimetry) from a sample of 100 patients included in AMI / AMImage 2 and relate them to brain imaging data (MRI). The main objective of the protocol is the evaluation of the link between changes in sleep and cycle parameters during aging and hippocampal functioning (through fMRI and neuropsychological score of hippocampal dependant tasks). The actimetry variables measured at the two follow-up (4 years apart) will make it possible to measure the degradation of the sleep and cycle parameters (through the reduction of sleep duration, sleep time, increase in sleep fragmentation and decrease in the relative amplitude of the rhythm). This framework will provide access to a very large amount of data that can be cross-referenced with actimetry data; the longitudinal character of this data collected over a decade will also make it possible to work on the evolution of the actimetry parameters and its relationship with the cognitive and clinical evolution of the subjects. Thus, these data will make it possible to study the prognostic value of the analyzed actimetry parameters in association with very complete clinical and neuropsychological data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Sleep
Keywords
Aging, Sleep/wake Cycle, Hippocampal connectivity, Hippocampal dependant Memory tests, Actigraphy, Functional and structural MRI

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sample of 100 persons included in AMI / AMImage 2
Arm Type
Experimental
Arm Description
Sample of 100 persons included in AMI / AMImage 2
Intervention Type
Other
Intervention Name(s)
Multimodal brain imaging (MRI)
Intervention Description
Multimodal brain imaging (MRI)
Intervention Type
Other
Intervention Name(s)
Actimetry
Intervention Description
7 days actimetry
Intervention Type
Other
Intervention Name(s)
Sleep Diary
Intervention Description
7 days Record of sleep and wake cycle
Primary Outcome Measure Information:
Title
Bold Signal
Description
Bold Signal on Magnetic Resonance Imaging (MRI)
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index (PSQI) Score
Description
seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality
Time Frame
Day 1
Title
Mannheim Dream questionnaire (MADRE)
Description
MADRE questionnaire evaluates dream recall frequency, emotional aspects of dreams (intensity and tonality), nightmares, lucid dreaming, attitude towards dreams, effects of dreams on waking life and dream literature reading and has been demonstrated to show high retest reliability
Time Frame
Day 1
Title
Epworth Sleepiness Scale
Description
The test is a list of eight situations in which is rate the tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing
Time Frame
Day 1
Title
Toronto Alexithymia Scale (TAS-20)
Description
The TAS-20 is a self-report scale that is comprised of 20 items. The TAS-20 has 3 subscales: Difficulty Describing Feelings subscale is used to measure difficulty describing emotions. 5 items. Difficulty Identifying Feeling subscale is used to measure difficulty identifying emotions. 7 items. Externally-Oriented Thinking subscale is used to measure the tendency of individuals to focus their attention externally. 8 items. Items are rated using a 5-point Likert scale whereby 1 = strongly disagree and 5 = strongly agree. The total alexithymia score is the sum of responses to all 20 items, while the score for each subscale factor is the sum of the responses to that subscale. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 = possible alexithymia.
Time Frame
Day 1
Title
Positive and Negative Affective Scale (PANAS)
Description
The PANAS Scale or Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire. The test comprises 20 terms, with ten focusing on a positive emotion and the other ten focusing on a negative emotion. The final score of the PANAS Scale / Positive and Negative Affect Schedule (PANAS) test is the sum of the 10 terms on the positive scale and the sum of the 10 terms on the negative scale. The value assigned is positive for answers on the positive scale and negative for answers on the negative scale.
Time Frame
Day 1
Title
Emotional Regulation Questionnaire (ERQ)
Description
10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). The scoring takes the average of all the scores.
Time Frame
Day 1
Title
Actimetry
Description
Automatically record of waking and sleeping periods on 7 consecutive days
Time Frame
Up to 7 days
Title
Sleep diary
Description
Series of questions for each 24-hour period with a collection of bedtime, wake-up time, possible night awakenings or even naps
Time Frame
Up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Belonging to AMImage 2 cohort and preferentially belonging to subjects included in the first actimetric assessment. AMI subjects have been selected based on Mutualité Sociale Agricole of Gironde (agricultural Health Insurance system database as followed : >65 years old Retired from agriculture Living in Gironde countryside Being affiliated to the French Farmers Health Insurance Signed Informed Consent Exclusion Criteria: Left Handed subjects Severe dementia (MMSE<13) Stroke Parkinson's disease MRI contraindication Health state not allowing displacement to the hospital Person under gardianship and not able to give its informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henri de CLERMONT-GALLERANDE
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33 076
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Sleep, Rhythms and Risk of Alzheimer's Disease

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