Assessment of Sleep Disturbance in Alzheimer Disease

• Sponsor: Centre Hospitalier Universitaire de Nice (Other)
• Overall Status: Completed
• CT.gov ID: NCT00831298
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arm: 1
• Duration (Months): 16
• Patients Per Site Per Month: 4.4

Study Details

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	Phase
Alzheimer Disease	Other: Analysis of sleep disturbance	N/A

Study Design

• Study Type: Interventional
• 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: Jul 1, 2010
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 [at day 0, just after inclusion]

Secondary Outcome Measures

1. assessment of sleep disturbance [during a week, between day 0 and day 7]

2. determine a genetic relationship between sleep disturbance and alzheimer disease [after all genetic analyses of the study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nice
• ClinicalTrials.gov Identifier: NCT00831298
• Other Study ID Numbers: 08-PP-07
• First Posted: Jan 28, 2009
• Last Update Posted: Dec 9, 2011
• Last Verified: Dec 1, 2011

• Keywords provided by Centre Hospitalier Universitaire de Nice: alzheimer disease; sleep disturbance; apathy; memory loss
• Additional relevant MeSH terms: Alzheimer Disease; Dyssomnias; Parasomnias

Study Results

No Results Posted as of Dec 9, 2011