Sleep, Cognition and Memory Disorder

Not Applicable

Completed

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

• Registration Number: NCT01650454
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-18
• Study First Submitted QC: 2012-07-23
• Study First Posted: 2012-07-26
• Study Start: 2013-01
• Primary Completion: 2015-10-29
• Study Completion: 2015-10-29
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-29
• Last Update Posted: 2021-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients from Memento cohort.	2 night polysomnography	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.
Patients with memory disorders	subjective evaluation of sleep and somnolence	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)
Patients from Memento cohort.	virtual reality test	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.
Healthy volunteers	subjective evaluation of sleep and somnolence	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)
control group	battery of neuropsychological tests	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.
control group	subjective evaluation of sleep and somnolence	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.
Patients from Memento cohort.	subjective evaluation of sleep and somnolence	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.
control group	virtual reality test	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.
Patients from Memento cohort.	battery of neuropsychological tests	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.
Patients with memory disorders	virtual reality test	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)
Healthy volunteers	virtual reality test	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)
control group	2 night polysomnography	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.

Primary Outcome Measures

Name	Time	Method
Polysomnography of night 1	Change from inclusion (Month 0) and Month 12	Actimetry: Inter-daily stability, intra-daily variability, rhythm amplitude

Secondary Outcome Measures

Name	Time	Method
Subjective evaluation of sleep and Somnolence	Month 0 and Month 12
Evaluation of Memory disorder	Month 0 and Month12	% of recall from the memory test in a virtual environment

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France