InsomniaNCT00901641
Computer-Based Cognitive Training and Sleep Quality in Older Adult Insomniacs
A study testing CogniFit Personal Coach® in people with Insomnia, run by The Max Stern Academic College Of Emek Yezreel at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- CogniFit Personal Coach®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteIsrael
- Study dates
- May 2003to Apr 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- diagnosis of chronic insomnia
- able to use a home personal computer
- have healthy dominant hand functioning
- Hebrew speakers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
The Max Stern Academic College of Emek Yezreel
Emek Yezreel, 19300
About this study
The purpose of this study is to investigate the effect of computerized, home-based cognitive training on sleep quality of older adults with insomnia.
Read the 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.
- Conditions
- Insomnia
- Being tested
- CogniFit Personal Coach®
- Keywords
- cognitive training, insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CogniFit Personal Coach®Device
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.
| Study group | Role | What they receive |
|---|---|---|
| cognitive training | Experimental | 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. Receives: Device: CogniFit Personal Coach® |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep measures
Measured: 3-6 months
Secondary outcomes (1)
Cognitive performance
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startMay 2003
- Primary completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Max Stern Academic College Of Emek Yezreel
- Sponsor type
- University, hospital or other
- Investigators
- Iris Haimov, Ph.D., Principal investigator, The Max Stern Academic College Of Emek Yezreel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901641
- Sponsor's protocol ID
- emek123-08
- Status last verified
- May 2009
- First submitted
- 12 May 2009
- Last updated
- 14 May 2009
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18412036Haimov 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.
PubMed 23577218
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Based Cognitive Training and Sleep Quality in Older Adult Insomniacs
- ClinicalTrials.gov ID
- NCT00901641
- Acronym / sponsor ID
- emek123-08
- Conditions
- Insomnia
- Keywords
- cognitive training, insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (actual)
- Lead sponsor
- The Max Stern Academic College Of Emek YezreelUniversity, hospital or other
- Study start
- May 2003
- Primary completion
- Apr 2009 (actual)
- First posted
- 14 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effect of computerized, home-based cognitive training on sleep quality of older adults with insomnia.
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 design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cognitive training | Experimental | Device: CogniFit Personal Coach®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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- diagnosis of chronic insomnia
- able to use a home personal computer
- have healthy dominant hand functioning
- Hebrew speakers
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | cognitive training |
Primary outcome
sleep measures
Time frame: 3-6 months
1 secondary outcome
Cognitive performance
Time frame: 3-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2009.
- Background: PubMed 18412036Haimov 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.
- Derived from this study: PubMed 23577218Haimov 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iris Haimov, Ph.D. principal investigator
The Max Stern Academic College Of Emek Yezreel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CogniFit Personal Coach® in people with Insomnia, run by The Max Stern Academic College Of Emek Yezreel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep measures (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00901641, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2009.