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Assessment of Sleep Disturbance in Alzheimer Disease

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Analysis of sleep disturbance
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alzheimer Disease focused on measuring alzheimer disease, sleep disturbance, apathy, memory loss

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Centre Mémoire de Ressources et de Recherche, CHU de Nice

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Behavioral Questionnaire Sleep Recordings Genetic analysis

Outcomes

Primary Outcome Measures

assessment of apathy

Secondary Outcome Measures

assessment of sleep disturbance
determine a genetic relationship between sleep disturbance and alzheimer disease

Full Information

First Posted
January 27, 2009
Last Updated
December 8, 2011
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT00831298
Brief Title
Assessment of Sleep Disturbance in Alzheimer Disease
Official Title
Assessment of Sleep Disturbance in Alzheimer Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
alzheimer disease, sleep disturbance, apathy, memory loss

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Behavioral Questionnaire Sleep Recordings Genetic analysis
Intervention Type
Other
Intervention Name(s)
Analysis of sleep disturbance
Intervention Description
Behavioral Questionnaire Sleep Recordings Genetic analysis
Primary Outcome Measure Information:
Title
assessment of apathy
Time Frame
at day 0, just after inclusion
Secondary Outcome Measure Information:
Title
assessment of sleep disturbance
Time Frame
during a week, between day 0 and day 7
Title
determine a genetic relationship between sleep disturbance and alzheimer disease
Time Frame
after all genetic analyses of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: alzheimer disease MMSE > 20 over 65 years old Exclusion Criteria: new psychotropic drug treatment patient unable to do neuropsychologic tests
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe ROBERT
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Mémoire de Ressources et de Recherche, CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France

12. IPD Sharing Statement

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Assessment of Sleep Disturbance in Alzheimer Disease

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