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Sleep, Cognition and Memory Disorder (SCOAL)

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ClinicalTrials.gov Identifier: NCT01650454
Recruitment Status : Unknown
Verified November 2014 by University Hospital, Bordeaux.
Recruitment status was:  Active, not recruiting
First Posted : July 26, 2012
Last Update Posted : November 11, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment Phase
Sleep Architecture Sleep Disorders Cognitive Impairment Other: 2 night polysomnography Other: battery of neuropsychological tests Other: virtual reality test Other: subjective evaluation of sleep and somnolence Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 185 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : January 2013
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: 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.

Other: 2 night polysomnography
Polysomnography

Other: battery of neuropsychological tests
Other: virtual reality test
Other: subjective evaluation of sleep and somnolence
Experimental: 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)
Other: virtual reality test
Other: subjective evaluation of sleep and somnolence
Active Comparator: 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)
Other: virtual reality test
Other: subjective evaluation of sleep and somnolence
Active Comparator: 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.
Other: 2 night polysomnography
Polysomnography

Other: battery of neuropsychological tests
Other: virtual reality test
Other: subjective evaluation of sleep and somnolence



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650454


Locations
France
CHU de Bordeaux
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Pierre Philip, Pr CHU Bordeaux

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01650454     History of Changes
Other Study ID Numbers: CHUBX 2012/02
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: November 11, 2014
Last Verified: November 2014

Keywords provided by University Hospital, Bordeaux:
Alzheimer
Sleep
Somnolence

Additional relevant MeSH terms:
Cognitive Dysfunction
Sleep Wake Disorders
Parasomnias
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms