Sleep, Cognition and Memory Disorder (SCOAL)

University Hospital of Bordeaux

Status: Completed

Conditions: Sleep Disorders; Cognitive Impairment; Sleep Architecture

Treatments: Other: 2 night polysomnography; Other: virtual reality test; Other: subjective evaluation of sleep and somnolence; Other: battery of neuropsychological tests

Study type: Interventional

Funder types: Other

Identifiers

NCT01650454

CHUBX 2012/02

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 4 patient groups

Patients from Memento cohort.

Experimental group

Description:

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.

Treatment:

Other: virtual reality test

Other: subjective evaluation of sleep and somnolence

Other: battery of neuropsychological tests

Other: 2 night polysomnography

Patients with memory disorders

Experimental group

Description:

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)

Treatment:

Other: virtual reality test

Other: subjective evaluation of sleep and somnolence

Healthy volunteers

Active Comparator group

Description:

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)

Treatment:

Other: virtual reality test

Other: subjective evaluation of sleep and somnolence

control group

Active Comparator group

Description:

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.

Treatment:

Other: virtual reality test

Other: subjective evaluation of sleep and somnolence

Other: battery of neuropsychological tests

Other: 2 night polysomnography