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Clinical Trials/NCT01650454
NCT01650454
Completed
Not Applicable

Sleep, Cognition and Memory Disorder

University Hospital, Bordeaux1 site in 1 country58 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Architecture
Sponsor
University Hospital, Bordeaux
Enrollment
58
Locations
1
Primary Endpoint
Polysomnography of night 1
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
October 29, 2015
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Polysomnography of night 1

Time Frame: Change from inclusion (Month 0) and Month 12

Actimetry: Inter-daily stability, intra-daily variability, rhythm amplitude

Secondary Outcomes

  • Subjective evaluation of sleep and Somnolence(Month 0 and Month 12)
  • Evaluation of Memory disorder(Month 0 and Month12)

Study Sites (1)

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