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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00901641
Other study ID # emek123-08
Secondary ID
Status Active, not recruiting
Phase N/A
First received May 12, 2009
Last updated May 13, 2009
Start date May 2003

Study information

Verified date May 2009
Source The Max Stern Academic College Of Emek Yezreel
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of computerized, home-based cognitive training on sleep quality of older adults with insomnia.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 51
Est. completion date
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility 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 Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
CogniFit Personal Coach®
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.

Locations

Country Name City State
Israel The Max Stern Academic College of Emek Yezreel Emek Yezreel

Sponsors (1)

Lead Sponsor Collaborator
The Max Stern Academic College Of Emek Yezreel

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary sleep measures 3-6 months No
Secondary Cognitive performance 3-6 months No
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