Sleep, Cognition and Memory Disorder - Full Text View

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:

MedlinePlus related topics: Dementia Memory Mild Cognitive Impairment Sleep Disorders

U.S. FDA Resources

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:	125
Study Start Date:	January 2013
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	July 2014 (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

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:

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

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:	February 19, 2013
Health Authority:	France: L’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 May 19, 2013

Sleep, Cognition and Memory Disorder (SCOAL)