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Assessment of Sleep Disturbance in Alzheimer Disease

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ClinicalTrials.gov Identifier: NCT00831298
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : December 9, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Alzheimer Disease Other: Analysis of sleep disturbance

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessment of Sleep Disturbance in Alzheimer Disease
Study Start Date : July 2010
Primary Completion Date : November 2011
Study Completion Date : November 2011


Arms and Interventions

Arm Intervention/treatment
1
Behavioral Questionnaire Sleep Recordings Genetic analysis
Other: Analysis of sleep disturbance
Behavioral Questionnaire Sleep Recordings Genetic analysis


Outcome Measures

Primary Outcome Measures :
  1. assessment of apathy [ Time Frame: at day 0, just after inclusion ]

Secondary Outcome Measures :
  1. assessment of sleep disturbance [ Time Frame: during a week, between day 0 and day 7 ]
  2. determine a genetic relationship between sleep disturbance and alzheimer disease [ Time Frame: after all genetic analyses of the study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00831298


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

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00831298     History of Changes
Other Study ID Numbers: 08-PP-07
First Posted: January 28, 2009    Key Record Dates
Last Update Posted: December 9, 2011
Last Verified: December 2011

Keywords provided by Centre Hospitalier Universitaire de Nice:
alzheimer disease
sleep disturbance
apathy
memory loss

Additional relevant MeSH terms:
Alzheimer Disease
Dyssomnias
Sleep Wake Disorders
Parasomnias
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Signs and Symptoms