Sleep, Cognition and Memory Disorder

Study Overview
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Brief Summary
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The increasing incidence of Alzheimer's disease (AD) and related sleep-disorders with the aging of the population is a major issue of public health. The prevalence of sleep disturbances is about 50% in dementia patients. Sleep in dementia is mainly characterized by prolonged night-time awakenings, sometimes with longer sleep latency and/or early awakening. The presence of these sleep disturbances is the main reason for the institutionalization of AD patients, as well as a major cause of the deterioration of the caregivers' sleep. The MEMENTO cohort is composed of patients with isolated memory complaints or mild cognitive impairment, at high risk to develop dementia. All voluntary patients from the CMRR (Center of Memory, resources and Research) of Bordeaux (MEMENTO cohort) will be tested at inclusion and followed-up 1 year later. For these two evaluations, actigraphic monitoring at home, 2-night polysomnography (PSG) monitoring at hospital including a 24-hour period of urinary melatonin dosage, neuropsychological tests battery, a virtual reality tool and questionnaires will be used.

Conditions
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Sleep Architecture, Sleep Disorders, Cognitive Impairment

Intervention / Treatment
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* Other: 2 night polysomnography
* Other: battery of neuropsychological tests
* Other: virtual reality test
* Other: subjective evaluation of sleep and somnolence


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for patients with mild cognitive impairment included in MEMENTO cohort: Aged 18 years and above included in MEMENTO cohort within the last 3 months Clinical dementia rating scale ≤ 0,5 (not demented) Patients with mild cognitive impairment Visual and auditory acuity adequate for neuropsychological testing Having signed an informed consent Being affiliated to health insurance Inclusion criteria for patients with mild cognitive impairment not included in MEMENTO cohort: Aged 18 years and above First contact with Memory clinic within the last 3 months Clinical dementia rating scale ≤ 0,5 (not demented) Patients with mild cognitive impairment Visual and auditory acuity adequate for neuropsychological testing Having signed an informed consent Being affiliated to health insurance Inclusion criteria for Healthy volunteers and Control group: Aged 18 years and above Without evidence of psychopathology Volunteers matched in age, sex and educational level with patients Visual and auditory acuity adequate for neuropsychological testing Having signed an informed consent Being affiliated to health insurance Exclusion criteria: Being under guardian conservator Residence in skilled nursing facility Pregnant or breast feeding woman Alzheimer's disease caused by gene mutations Having a neurological disease History of stroke within the past three months Generalized anxiety (DSM-IV criteria) Schizophrenia history (DSM-IV criteria) Illiteracy, is unable to count or to read

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients from Memento cohort.<br>Patients with mild cognitive impairment included in MEMENTO cohort. These patients will have a 2 night polysomnography, a battery of neuropsychological tests, a virtual reality test, and a subjective evaluation of sleep and somnolence at inclusion (Month 0) and Month 12. | Other: 2 night polysomnography<br>* Polysomnography<br>Other: battery of neuropsychological tests<br> <br> Other: virtual reality test<br> <br> Other: subjective evaluation of sleep and somnolence<br> <br> |
| Experimental: Patients with memory disorders<br>Patients with mild cognitive impairment not included in MEMENTO cohort. For these patients a virtual reality test, and a subjective evaluation of sleep and somnolence will be performed at Inclusion (Month 0) | Other: virtual reality test<br> <br> Other: subjective evaluation of sleep and somnolence<br> <br> |
| Active Comparator: Healthy volunteers<br>Healthy volunteers matched in age, sex and educational level with patients. For these volunteers a virtual reality test, and a subjective evaluation of sleep and somnolence will be performed at Inclusion (Month 0) | Other: virtual reality test<br> <br> Other: subjective evaluation of sleep and somnolence<br> <br> |
| Active Comparator: control group<br>this group is composed with Healthy volunteers these volunteers will have a 2 night polysomnography, a battery of neuropsychological tests, a virtual reality test, and a subjective evaluation of sleep and somnolence at inclusion (Month 0) and Month 12. | Other: 2 night polysomnography<br>* Polysomnography<br>Other: battery of neuropsychological tests<br> <br> Other: virtual reality test<br> <br> Other: subjective evaluation of sleep and somnolence<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polysomnography of night 1 | - Apnea/Hypopnea index, periodic limb movements index | Change from inclusion (Month 0) and Month 12 | 
| Polysomnography of night 1 | - Excessive transient muscle activity, Sustained muscle activity | Change from inclusion (Month 0) and Month 12 | 
| Polysomnography of night 1 | - Sleep structure parameters (% stage 1, 2, 3 and Rapid Eye movement, Delta activity, Spindle rate) | Change from inclusion (Month 0) and Month 12 | 
| Polysomnography of night 1 | - Sleep duration parameters | Change from inclusion (Month 0) and Month 12 | 
| Polysomnography of night 1 | - Sleep consolidation parameters | Change from inclusion (Month 0) and Month 12 | 
| Polysomnography of night 1 | - Sleep propensity parameters 24-hour melatonin quantity rate | Change from inclusion (Month 0) and Month 12 | 
| Polysomnography of night 1 | Actimetry: Inter-daily stability, intra-daily variability, rhythm amplitude | Change from inclusion (Month 0) and Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective evaluation of sleep and Somnolence |  | Month 0 and Month 12 | 
| Evaluation of Memory disorder | Reaction times and % of errors in the neuropsychological tests (memory, speed processing, language, visuo-spatial skills, attentional functions, executive functions) | Month 0 and Month12 | 
| Evaluation of Memory disorder | % of recall from the memory test in a virtual environment | Month 0 and Month12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer, Sleep, Somnolence