Overview

This trial is active, not recruiting.

Conditions sleep architecture, sleep disorders, cognitive impairment
Treatments 2 night polysomnography, battery of neuropsychological tests, virtual reality test, subjective evaluation of sleep and somnolence
Sponsor University Hospital, Bordeaux
Start date January 2013
End date October 2015
Trial size 185 participants
Trial identifier NCT01650454, CHUBX 2012/02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
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.
2 night polysomnography
Polysomnography
battery of neuropsychological tests
virtual reality test
subjective evaluation of sleep and somnolence
(Experimental)
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)
virtual reality test
subjective evaluation of sleep and somnolence
(Active Comparator)
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)
virtual reality test
subjective evaluation of sleep and somnolence
(Active Comparator)
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.
2 night polysomnography
Polysomnography
battery of neuropsychological tests
virtual reality test
subjective evaluation of sleep and somnolence

Primary Outcomes

Measure
Polysomnography of night 1
time frame: Change from inclusion (Month 0) and Month 12
Polysomnography of night 1
time frame: Change from inclusion (Month 0) and Month 12
Polysomnography of night 1
time frame: Change from inclusion (Month 0) and Month 12
Polysomnography of night 1
time frame: Change from inclusion (Month 0) and Month 12
Polysomnography of night 1
time frame: Change from inclusion (Month 0) and Month 12
Polysomnography of night 1
time frame: Change from inclusion (Month 0) and Month 12
Polysomnography of night 1
time frame: Change from inclusion (Month 0) and Month 12

Secondary Outcomes

Measure
Subjective evaluation of sleep and Somnolence
time frame: Month 0 and Month 12
Evaluation of Memory disorder
time frame: Month 0 and Month12
Evaluation of Memory disorder
time frame: Month 0 and Month12

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Principal investigator Pierre Philip, Pr
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by University Hospital, Bordeaux.