Clinical trial NCT01650454: Sleep, Cognition and Memory Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Architecture
Sleep Disorders
Cognitive Impairment
Keywords: Alzheimer
Sleep
Somnolence
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2012-07-26
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Polysomnography of night 1
timeFrame: Change from inclusion (Month 0) and Month 12
measure: Polysomnography of night 1
timeFrame: Change from inclusion (Month 0) and Month 12
measure: Polysomnography of night 1
timeFrame: Change from inclusion (Month 0) and Month 12
measure: Polysomnography of night 1
timeFrame: Change from inclusion (Month 0) and Month 12
measure: Polysomnography of night 1
timeFrame: Change from inclusion (Month 0) and Month 12
measure: Polysomnography of night 1
timeFrame: Change from inclusion (Month 0) and Month 12
measure: Polysomnography of night 1
timeFrame: Change from inclusion (Month 0) and Month 12
Secondary outcomes:
measure: Subjective evaluation of sleep and Somnolence
timeFrame: Month 0 and Month 12
measure: Evaluation of Memory disorder
timeFrame: Month 0 and Month12
measure: Evaluation of Memory disorder
timeFrame: Month 0 and Month12
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Pierre Philip, Pr
role: PRINCIPAL_INVESTIGATOR
References: