Back to results

Sleep, Cognition and Memory Disorder (SCOAL)

Primary Purpose

Sleep Architecture, Sleep Disorders, Cognitive Impairment

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

2 night polysomnography

battery of neuropsychological tests

virtual reality test

subjective evaluation of sleep and somnolence

About this trial

This is an interventional basic science trial for Sleep Architecture focused on measuring Alzheimer, Sleep, Somnolence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

CHU de Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Patients from Memento cohort.

Patients with memory disorders

Healthy volunteers

control group

Arm Description

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 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 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)

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.

Outcomes

Primary Outcome Measures

Polysomnography of night 1

- Apnea/Hypopnea index, periodic limb movements index

Polysomnography of night 1

- Excessive transient muscle activity, Sustained muscle activity

Polysomnography of night 1

- Sleep structure parameters (% stage 1, 2, 3 and Rapid Eye movement, Delta activity, Spindle rate)

Polysomnography of night 1

- Sleep duration parameters

Polysomnography of night 1

- Sleep consolidation parameters

Polysomnography of night 1

- Sleep propensity parameters 24-hour melatonin quantity rate

Polysomnography of night 1

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

Secondary Outcome Measures

Subjective evaluation of sleep and Somnolence

Evaluation of Memory disorder

Reaction times and % of errors in the neuropsychological tests (memory, speed processing, language, visuo-spatial skills, attentional functions, executive functions)

Evaluation of Memory disorder

% of recall from the memory test in a virtual environment

Full Information

NCT ID

NCT01650454

First Posted

July 18, 2012

Last Updated

June 29, 2021

Sponsor

University Hospital, Bordeaux

1. Study Identification

Unique Protocol Identification Number

NCT01650454

Brief Title

Sleep, Cognition and Memory Disorder

Acronym

SCOAL

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

October 29, 2015 (Actual)

Study Completion Date

October 29, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Architecture, Sleep Disorders, Cognitive Impairment

Keywords

Alzheimer, Sleep, Somnolence

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients from Memento cohort.

Arm Type

Experimental

Arm Description

Arm Title

Patients with memory disorders

Arm Type

Experimental

Arm Description

Arm Title

Healthy volunteers

Arm Type

Active Comparator

Arm Description

Arm Title

control group

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

2 night polysomnography

Intervention Description

Polysomnography

Intervention Type

Other

Intervention Name(s)

battery of neuropsychological tests

Intervention Type

Other

Intervention Name(s)

virtual reality test

Intervention Type

Other

Intervention Name(s)

subjective evaluation of sleep and somnolence

Primary Outcome Measure Information:

Title

Polysomnography of night 1

Description

- Apnea/Hypopnea index, periodic limb movements index

Time Frame