Sleep, Cognition and Memory Disorder (SCOAL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01650454
First received: July 18, 2012
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Polysomnography of night 1 [ Time Frame: Change from inclusion (Month 0) and Month 12 ] [ Designated as safety issue: No ]
    - Apnea/Hypopnea index, periodic limb movements index

  • Polysomnography of night 1 [ Time Frame: Change from inclusion (Month 0) and Month 12 ] [ Designated as safety issue: No ]
    - Excessive transient muscle activity, Sustained muscle activity

  • Polysomnography of night 1 [ Time Frame: Change from inclusion (Month 0) and Month 12 ] [ Designated as safety issue: No ]
    - Sleep structure parameters (% stage 1, 2, 3 and Rapid Eye movement, Delta activity, Spindle rate)

  • Polysomnography of night 1 [ Time Frame: Change from inclusion (Month 0) and Month 12 ] [ Designated as safety issue: No ]
    - Sleep duration parameters

  • Polysomnography of night 1 [ Time Frame: Change from inclusion (Month 0) and Month 12 ] [ Designated as safety issue: No ]
    - Sleep consolidation parameters

  • Polysomnography of night 1 [ Time Frame: Change from inclusion (Month 0) and Month 12 ] [ Designated as safety issue: No ]
    - Sleep propensity parameters 24-hour melatonin quantity rate

  • Polysomnography of night 1 [ Time Frame: Change from inclusion (Month 0) and Month 12 ] [ Designated as safety issue: No ]
    Actimetry: Inter-daily stability, intra-daily variability, rhythm amplitude


Secondary Outcome Measures:
  • Subjective evaluation of sleep and Somnolence [ Time Frame: Month 0 and Month 12 ] [ Designated as safety issue: No ]
  • Evaluation of Memory disorder [ Time Frame: Month 0 and Month12 ] [ Designated as safety issue: No ]
    Reaction times and % of errors in the neuropsychological tests (memory, speed processing, language, visuo-spatial skills, attentional functions, executive functions)

  • Evaluation of Memory disorder [ Time Frame: Month 0 and Month12 ] [ Designated as safety issue: No ]
    % of recall from the memory test in a virtual environment


Estimated Enrollment: 185
Study Start Date: January 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650454

Contacts
Contact: Pierre Philip, Pr 05 57 82 01 72 ext +33 pierre.philip@chu-bordeaux.fr

Locations
France
CHU de Bordeaux Recruiting
Bordeaux, France, 33076
Contact: Pierre Philip, Pr    05 57 82 01 72 ext +33    pierre.philip@chu-bordeaux.fr   
Principal Investigator: Pierre Philip, Pr         
Sub-Investigator: Olivier Coste, Dr         
Sub-Investigator: Pierre-Jean Monteyrol, Dr         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Pierre Philip, Pr CHU Bordeaux
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01650454     History of Changes
Other Study ID Numbers: CHUBX 2012/02
Study First Received: July 18, 2012
Last Updated: March 31, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Bordeaux:
Alzheimer
Sleep
Somnolence

Additional relevant MeSH terms:
Memory Disorders
Sleep Disorders
Parasomnias
Cognition Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders

ClinicalTrials.gov processed this record on September 14, 2014