Sleep, Cognition and Memory Disorder (SCOAL)

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment; Sleep Disorders; Sleep Architecture
• Intervention / Treatment: Other: 2 night polysomnography; Other: battery of neuropsychological tests; Other: virtual reality test; Other: subjective evaluation of sleep and somnolence

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polysomnography of night 1	- Apnea/Hypopnea index, periodic limb movements index	Change from inclusion (Month 0) and Month 12
Polysomnography of night 1	- Excessive transient muscle activity, Sustained muscle activity	Change from inclusion (Month 0) and Month 12
Polysomnography of night 1	- Sleep structure parameters (% stage 1, 2, 3 and Rapid Eye movement, Delta activity, Spindle rate)	Change from inclusion (Month 0) and Month 12
Polysomnography of night 1	- Sleep duration parameters	Change from inclusion (Month 0) and Month 12
Polysomnography of night 1	- Sleep consolidation parameters	Change from inclusion (Month 0) and Month 12
Polysomnography of night 1	- Sleep propensity parameters 24-hour melatonin quantity rate	Change from inclusion (Month 0) and Month 12
Polysomnography of night 1	Actimetry: Inter-daily stability, intra-daily variability, rhythm amplitude	Change from inclusion (Month 0) and Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective evaluation of sleep and Somnolence		Month 0 and Month 12
Evaluation of Memory disorder	Reaction times and % of errors in the neuropsychological tests (memory, speed processing, language, visuo-spatial skills, attentional functions, executive functions)	Month 0 and Month12
Evaluation of Memory disorder	% of recall from the memory test in a virtual environment	Month 0 and Month12

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Pierre PHILIP, Pr, CHU Bordeaux

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): October 29, 2015
• Study Completion (Actual): October 29, 2015

Study Registration Dates

• First Submitted: July 18, 2012
• First Submitted That Met QC Criteria: July 23, 2012
• First Posted (Estimate): July 26, 2012

Study Record Updates

• Last Update Posted (Actual): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Sleep; Alzheimer; Somnolence
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders
• Other Study ID Numbers: CHUBX 2012/02