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What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Sleep Architecture

Sleep Disorders

Cognitive Impairment

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:2 night polysomnographyPolysomnography

Other:battery of neuropsychological tests

Other:virtual reality test

Other:subjective evaluation of sleep and somnolence

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Patients from Memento cohort.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.

Patients with memory disordersPatients 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)

Healthy volunteersHealthy 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)

control groupthis 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.

Study Status

Unknown status

Start Date: January 2013

Completed Date: October 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Polysomnography of night 1

Secondary Outcome: Subjective evaluation of sleep and Somnolence

Study sponsors, principal investigator, and references

Principal Investigator: Pierre Philip, Pr

Lead Sponsor: University Hospital, Bordeaux

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01650454