Sleep, Cognition and Memory Disorder

NCT ID: NCT01650454

Last Updated: 2021-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-10-29

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.

Detailed Description

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Conditions

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Sleep Architecture Sleep Disorders Cognitive Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

2 night polysomnography

Intervention Type OTHER

Polysomnography

battery of neuropsychological tests

Intervention Type OTHER

virtual reality test

Intervention Type OTHER

subjective evaluation of sleep and somnolence

Intervention Type OTHER

Patients with memory disorders

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)

Group Type EXPERIMENTAL

virtual reality test

Intervention Type OTHER

subjective evaluation of sleep and somnolence

Intervention Type OTHER

Healthy volunteers

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)

Group Type ACTIVE_COMPARATOR

virtual reality test

Intervention Type OTHER

subjective evaluation of sleep and somnolence

Intervention Type OTHER

control group

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.

Group Type ACTIVE_COMPARATOR

2 night polysomnography

Intervention Type OTHER

Polysomnography

battery of neuropsychological tests

Intervention Type OTHER

virtual reality test

Intervention Type OTHER

subjective evaluation of sleep and somnolence

Intervention Type OTHER

Interventions

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2 night polysomnography

Polysomnography

Intervention Type OTHER

battery of neuropsychological tests

Intervention Type OTHER

virtual reality test

Intervention Type OTHER

subjective evaluation of sleep and somnolence

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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


* 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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Philip, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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CHU de Bordeaux

Bordeaux, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2012/02

Identifier Type: -

Identifier Source: org_study_id

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