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Sleep, Cognition and Memory Disorder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01650454
Acronym
SCOAL
Enrollment
58
Registered
2012-07-26
Start date
2013-01-31
Completion date
2015-10-29
Last updated
2021-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment, Sleep Architecture, Sleep Disorders

Keywords

Alzheimer, Sleep, Somnolence

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.

Interventions

OTHER2 night polysomnography

Polysomnography

OTHERbattery of neuropsychological tests
OTHERvirtual reality test
OTHERsubjective evaluation of sleep and somnolence

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Polysomnography of night 1Change from inclusion (Month 0) and Month 12\- Apnea/Hypopnea index, periodic limb movements index

Secondary

MeasureTime frameDescription
Subjective evaluation of sleep and SomnolenceMonth 0 and Month 12
Evaluation of Memory disorderMonth 0 and Month12Reaction times and % of errors in the neuropsychological tests (memory, speed processing, language, visuo-spatial skills, attentional functions, executive functions)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026