Assessment of Sleep Disturbance in Alzheimer Disease

Verified by: Centre Hospitalier Universitaire de Nice, December 2011
First Received: January 27, 2009 | Last Updated: December 8, 2011 | Phase: N/A | Start Date: July 2010
Overall Status: Completed | Estimated Enrollment: 70
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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...

Brief Summary

Official Title: “Assessment of Sleep Disturbance in Alzheimer Disease”

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

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
  • Study Primary Completion Date: November 2011

Intervention(s) in this Clinical Trial

  • Other: Analysis of sleep disturbance
    • Behavioral Questionnaire Sleep Recordings Genetic analysis

Arms, Groups and Cohorts in this Clinical Trial

  • Other: 1
    • Behavioral Questionnaire Sleep Recordings Genetic analysis

Outcome Measures for this Clinical Trial

Primary Measures

  • assessment of apathy
    • Time Frame: at day 0, just after inclusion
      Safety Issue?: No

Secondary Measures

  • assessment of sleep disturbance
    • Time Frame: during a week, between day 0 and day 7
      Safety Issue?: No
  • determine a genetic relationship between sleep disturbance and alzheimer disease
    • Time Frame: after all genetic analyses of the study
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • alzheimer disease
  • MMSE > 20
  • over 65 years old

Exclusion Criteria:

  • new psychotropic drug treatment
  • patient unable to do neuropsychologic tests

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 65 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: Centre Hospitalier Universitaire de Nice Other

Overall Clinical Trial Officials and Contacts

Philippe ROBERT Principal Investigator Centre Hospitalier Universitaire de Nice  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00831298

Study ID Number: 08-PP-07

ClinicalTrials.gov Identifier: NCT00831298

Health Authority: France: Afssaps - French Health Products Safety Agency

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00831298