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Completed

NCT Number: NCT01650454

Sleep, Cognition and Memory Disorder

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.

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Key information

Conditions

Sleep Architecture Cognition Disorders Cognitive Dysfunction Cognitive Impairment Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders Sleep Wake Disorders Sleepiness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux

Bordeaux, 33076, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2 night polysomnography

Other

Polysomnography

battery of neuropsychological tests

Other

virtual reality test

Other

subjective evaluation of sleep and somnolence

Other

Primary outcomes

  1. Polysomnography of night 1

    Time frame: Change from inclusion (Month 0) and Month 12

    • Apnea/Hypopnea index, periodic limb movements index

  2. Polysomnography of night 1

    Time frame: Change from inclusion (Month 0) and Month 12

    • Excessive transient muscle activity, Sustained muscle activity

  3. Polysomnography of night 1

    Time frame: Change from inclusion (Month 0) and Month 12

    • Sleep structure parameters (% stage 1, 2, 3 and Rapid Eye movement, Delta activity, Spindle rate)

  4. Polysomnography of night 1

    Time frame: Change from inclusion (Month 0) and Month 12

    • Sleep duration parameters

  5. Polysomnography of night 1

    Time frame: Change from inclusion (Month 0) and Month 12

    • Sleep consolidation parameters

  6. Polysomnography of night 1

    Time frame: Change from inclusion (Month 0) and Month 12

    • Sleep propensity parameters 24-hour melatonin quantity rate

  7. Polysomnography of night 1

    Time frame: Change from inclusion (Month 0) and Month 12

    Actimetry: Inter-daily stability, intra-daily variability, rhythm amplitude

Secondary outcomes

  1. Subjective evaluation of sleep and Somnolence

    Time frame: Month 0 and Month 12

  2. Evaluation of Memory disorder

    Time frame: Month 0 and Month12

    Reaction times and % of errors in the neuropsychological tests (memory, speed processing, language, visuo-spatial skills, attentional functions, executive functions)

  3. Evaluation of Memory disorder

    Time frame: Month 0 and Month12

    % of recall from the memory test in a virtual environment

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: SCOAL

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 26, 2012
Registry last updated
Jul 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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