Assessment of Sleep Disturbance in Alzheimer Disease

This study is not yet open for participant recruitment.

Verified by Centre Hospitalier Universitaire de Nice, January 2009

First Received: January 27, 2009 No Changes Posted

Sponsored by:	Centre Hospitalier Universitaire de Nice
Information provided by:	Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:	NCT00831298

Purpose

The purpose of this study is to study circadian rhythms, or daily cycles of sleep, wake, and activity. The investigators hope to learn how disturbed sleep in Alzheimer's Disease relates to changes in activity cycles, and how sleep disturbances may affect your daytime alertness.

This project selects patients suffering from memory problems, or voluntary to be in our Control Group. There are three parts to this study: Sleep Diaries, Behavioral Questionnaire, and Activity Recordings

Condition	Intervention
Alzheimer Disease	Other: Analysis of sleep disturbance

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Memory Sleep Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment
Official Title:	Assessment of Sleep Disturbance in Alzheimer Disease

Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:

assessment of apathy [ Time Frame: at day 0, just after inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

assessment of sleep disturbance [ Time Frame: during a week, between day 0 and day 7 ] [ Designated as safety issue: No ]
determine a genetic relationship between sleep disturbance and alzheimer disease [ Time Frame: after all genetic analyses of the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	February 2009
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Behavioral Questionnaire Sleep Recordings Genetic analysis	Other: Analysis of sleep disturbance Behavioral Questionnaire Sleep Recordings Genetic analysis

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

alzheimer disease
MMSE > 20
over 65 years old

Exclusion Criteria:

new psychotropic drug treatment
patient unable to do neuropsychologic tests

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831298

Contacts

Contact: Philippe Robert		robert.ph@chu-nice.fr
Contact: Renaud David		renaud.d@chu-nice.fr

Locations

France
Centre Mémoire de Ressources et de Recherche, CHU de Nice
NICE, France, 06000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

Principal Investigator:

Philippe ROBERT

Centre Hospitalier Universitaire de Nice

More Information

No publications provided

Responsible Party:	Centre Hospitalier Universitaire de Nice ( Département de la Recherche Clinique et de l'Innovation )
Study ID Numbers:	08-PP-07
Study First Received:	January 27, 2009
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00831298 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; France: French Data Protection Authority; France: Institutional Ethical Committee

Keywords provided by Centre Hospitalier Universitaire de Nice:

alzheimer disease
sleep disturbance
apathy
memory loss

Study placed in the following topic categories:

Alzheimer Disease
Sleep Disorders
Dyssomnias
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Cognition Disorders

Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurologic Manifestations
Dementia
Amnesia
Delirium

Additional relevant MeSH terms:

Alzheimer Disease
Nervous System Diseases
Dyssomnias
Sleep Disorders
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases

Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurologic Manifestations
Dementia
Tauopathies

ClinicalTrials.gov processed this record on May 06, 2009