- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00901641
Computer-Based Cognitive Training and Sleep Quality in Older Adult Insomniacs
May 13, 2009 updated by: The Max Stern Academic College Of Emek Yezreel
The purpose of this study is to investigate the effect of computerized, home-based cognitive training on sleep quality of older adults with insomnia.
Study Overview
Detailed Description
Participants in the cognitive training group train in a computer-based cognitive training program over a period of 12 weeks.
An active control group train in a program involving tasks that do not engage high-level cognitive functioning over the same period.
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Emek Yezreel, Israel, 19300
- The Max Stern Academic College of Emek Yezreel
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnosis of chronic insomnia
- able to use a home personal computer
- have healthy dominant hand functioning
- Hebrew speakers
Exclusion Criteria:
- have any significant visual or hearing impairment
- have any significant medical, neurological or psychiatric illness that might bring about cognitive change
- have sleep disorders other than insomnia
- have any significant medical disease (including cancer, diabetes, liver, kidney, heart or lung disease)
- alcoholism or other drug abuse
- taking any medication known to affect central nervous system functioning other than sleeping pills
- historical evidence suggesting significant psychiatric conditions such as depression, psychosis or neurologic disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: cognitive training
CogniFit Personal Coach® computer cognitive training program.
The program provides individually tailored cognitive training based on the results of a baseline evaluation (the Neuropsychological Examination - CogniFit Personal Coach®).
The program assigns scores to 17 cognitive abilities that are subsequently trained by means of 21 different tasks.
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The program provides individually tailored cognitive training based on the results of a baseline evaluation (the Neuropsychological Examination - CogniFit Personal Coach®).7 The program assigns scores to 17 cognitive abilities that are subsequently trained by means of 21 different tasks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
sleep measures
Time Frame: 3-6 months
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3-6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cognitive performance
Time Frame: 3-6 months
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3-6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Iris Haimov, Ph.D., The Max Stern Academic College of Emek Yezreel
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Haimov I, Hanuka E, Horowitz Y. Chronic insomnia and cognitive functioning among older adults. Behav Sleep Med. 2008;6(1):32-54. doi: 10.1080/15402000701796080.
- Haimov I, Shatil E. Cognitive training improves sleep quality and cognitive function among older adults with insomnia. PLoS One. 2013;8(4):e61390. doi: 10.1371/journal.pone.0061390. Epub 2013 Apr 5.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2003
Primary Completion (ACTUAL)
April 1, 2009
Study Registration Dates
First Submitted
May 12, 2009
First Submitted That Met QC Criteria
May 13, 2009
First Posted (ESTIMATE)
May 14, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
May 14, 2009
Last Update Submitted That Met QC Criteria
May 13, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- emek123-08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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