Sleep, Cognition and Memory Disorder

Cognitive Impairment Clinical Trial

— SCOAL  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650454
• Other study ID #: CHUBX 2012/02
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: October 29, 2015

Study information

• Verified date: June 2021
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: October 29, 2015
• Est. primary completion date: October 29, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Impairment
• Sleep Architecture
• Sleep Disorders
• Sleep Wake Disorders

Intervention

Other:
• 2 night polysomnography
Polysomnography
• battery of neuropsychological tests

• virtual reality test

• subjective evaluation of sleep and somnolence

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polysomnography of night 1	- Apnea/Hypopnea index, periodic limb movements index	Change from inclusion (Month 0) and Month 12
Primary	Polysomnography of night 1	- Excessive transient muscle activity, Sustained muscle activity	Change from inclusion (Month 0) and Month 12
Primary	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
Primary	Polysomnography of night 1	- Sleep duration parameters	Change from inclusion (Month 0) and Month 12
Primary	Polysomnography of night 1	- Sleep consolidation parameters	Change from inclusion (Month 0) and Month 12
Primary	Polysomnography of night 1	- Sleep propensity parameters 24-hour melatonin quantity rate	Change from inclusion (Month 0) and Month 12
Primary	Polysomnography of night 1	Actimetry: Inter-daily stability, intra-daily variability, rhythm amplitude	Change from inclusion (Month 0) and Month 12
Secondary	Subjective evaluation of sleep and Somnolence		Month 0 and Month 12
Secondary	Evaluation of Memory disorder	Reaction times and % of errors in the neuropsychological tests (memory, speed processing, language, visuo-spatial skills, attentional functions, executive functions)	Month 0 and Month12
Secondary	Evaluation of Memory disorder	% of recall from the memory test in a virtual environment	Month 0 and Month12