NCT01650454

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 26, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2015

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

2.8 years

First QC Date

July 18, 2012

Last Update Submit

June 29, 2021

Conditions

Sleep ArchitectureSleep DisordersCognitive Impairment

Keywords

AlzheimerSleepSomnolence

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (3)

  • Subjective evaluation of sleep and Somnolence

    Month 0 and Month 12

  • Evaluation of Memory disorder

    Month 0 and Month12

  • Evaluation of Memory disorder

    Month 0 and Month12

Study Arms (4)

Patients from Memento cohort.

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.

Other: 2 night polysomnographyOther: battery of neuropsychological testsOther: virtual reality testOther: subjective evaluation of sleep and somnolence

Patients with memory disorders

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)

Other: virtual reality testOther: subjective evaluation of sleep and somnolence

Healthy volunteers

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)

Other: virtual reality testOther: subjective evaluation of sleep and somnolence

control group

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.

Other: 2 night polysomnographyOther: battery of neuropsychological testsOther: virtual reality testOther: subjective evaluation of sleep and somnolence

Interventions

2 night polysomnographyOTHER

Polysomnography

Patients from Memento cohort.control group
battery of neuropsychological testsOTHER
Patients from Memento cohort.control group
virtual reality testOTHER
Healthy volunteersPatients from Memento cohort.Patients with memory disorderscontrol group
subjective evaluation of sleep and somnolenceOTHER
Healthy volunteersPatients from Memento cohort.Patients with memory disorderscontrol group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • Aged 18 years and above
  • +5 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Sleep Wake DisordersCognitive DysfunctionSleepiness

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersCognition DisordersNeurocognitive Disorders

Study Officials

  • Pierre Philip, Pr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2012

First Posted

July 26, 2012

Study Start

January 1, 2013

Primary Completion

October 29, 2015

Study Completion

October 29, 2015

Last Updated

July 1, 2021

Record last verified: 2021-06

Locations

FR(1)