Assessment of Sleep Disturbance in Alzheimer Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00831298
First received: January 27, 2009
Last updated: December 8, 2011
Last verified: December 2011
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Assessment of Sleep Disturbance in Alzheimer Disease

Resource links provided by NLM:


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 ]

Enrollment: 70
Study Start Date: July 2010
Study Completion Date: November 2011
Primary Completion Date: November 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00831298     History of Changes
Other Study ID Numbers: 08-PP-07
Study First Received: January 27, 2009
Last Updated: December 8, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority
France: Institutional Ethical Committee

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

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

ClinicalTrials.gov processed this record on July 22, 2014