Healthy VolunteersNCT02614755
An Observational Study of Lumosity in Seniors
An observational study of Healthy Volunteers, run by Lumos Labs, Inc. at 1 site in United States.
Trial summary
The primary objective of this observational study is to determine performance characteristics and usability of Lumosity and the Brain Performance Test in a group of older adult volunteers. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 23 May 2017
- Phase
- Observational
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants must be cognitively stable older adult volunteers(over 55 years of age)
Who may be able to join
- Participants must meet the following criteria:
- 55 years of age or older
- English-speaker
- Cognitively stable (i.e., without a known diagnosis that may affect cognitive abilities)
- Regular access to and ability to use a computer or mobile device with Internet connectivity.
Who cannot join
- Under 55 years of age
- Have a current diagnosed cognitive or neuropsychological condition
- Are taking medication that may impede cognitive functioning
- Anticipate a dosage change in medication that may affect cognitive functioning during the course of the study (24 weeks)
- Have other conditions or problems that may preclude regular computer usage
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this observational study is to determine performance characteristics and usability of Lumosity and the Brain Performance Test in a group of older adult volunteers.
Read the detailed description
Approximately 200 prospective users currently will be provided free 6-month premium access Lumosity accounts. Participants will be provided with an account activation code and instructed on how to sign up for Lumosity with their email address. They will be subject to the Lumosity Terms of Service and follow the typical user experience. Upon creating an account, users would be asked to complete a short demographic survey that includes questions on gender, education, occupation, years since retirement, health, computer familiarity, and perceptions of brain training.
Those who sign up will have immediate access to the Lumosity training system and the entire suite of Lumosity games. In addition, they will be invited, via email, to take the Brain Performance Test one week after the initial sign-up and then again 12 weeks later. Approximately every 8 weeks, users will be asked to complete a short questionnaire about their experience with Lumosity. This questionnaire will be accessed via email. Participants will be asked to train 5 days a week for 20-30 minutes per day, but are free to play as much or a little as they choose. Community associates at the sites will be encouraged to host group training sessions, giving the seniors a chance to gather and complete their training together, share their experiences, and get any help they may need. In addition, sites will have the option of hosting 1-2 focus groups with participants and researchers from Lumos Labs. The focus groups will be an opportunity to give and receive direct feedback about Lumosity, and get any questions answered by the researchers.
- Conditions
- Healthy Volunteers
- Keywords
- Older Adults Volunteers, Seniors, Brain Performance Test
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability - as measured by self-report feedback surveys
Using self-report surveys administered to participants at baseline, 3 months and 6 months, investigators will calculate a usability score of Lumosity.
Measured: Change from Baseline - collected at baseline, 3 months and 6 months
Secondary outcomes (3)
User Engagement - as measured by number of unique days played
Calculating the number of unique days played will allow us to estimate the engagement level of study participants.
Measured: 6 months
Change from baseline on the Lumosity Performance Index (LPI)
To evaluate the Lumosity Performance Index (LPI) results in a group of seniors
Measured: Change from Baseline - collected at baseline and 6 months
Change from baseline on the Brain Performance Test (BPT)
To evaluate the Brain Performance Test (BPT) results in a group of seniors
Measured: Change from Baseline - collected at baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startNov 2015
- Primary completion23 May 2017
- Study completion23 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumos Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glenn Morrison, PhD, Principal investigator, Lumos Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614755
- Sponsor's protocol ID
- LL004
- Status last verified
- May 2017
- First submitted
- 18 Nov 2015
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Lumosity in Seniors
- ClinicalTrials.gov ID
- NCT02614755
- Acronym / sponsor ID
- LL004
- Conditions
- Healthy Volunteers
- Keywords
- Older Adults Volunteers, Seniors, Brain Performance Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Lumos Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- 23 May 2017 (actual)
- Study completion
- 23 May 2017 (actual)
- First posted
- 25 Nov 2015 (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 primary objective of this observational study is to determine performance characteristics and usability of Lumosity and the Brain Performance Test in a group of older adult volunteers.
Detailed description
Approximately 200 prospective users currently will be provided free 6-month premium access Lumosity accounts. Participants will be provided with an account activation code and instructed on how to sign up for Lumosity with their email address. They will be subject to the Lumosity Terms of Service and follow the typical user experience. Upon creating an account, users would be asked to complete a short demographic survey that includes questions on gender, education, occupation, years since retirement, health, computer familiarity, and perceptions of brain training.
Those who sign up will have immediate access to the Lumosity training system and the entire suite of Lumosity games. In addition, they will be invited, via email, to take the Brain Performance Test one week after the initial sign-up and then again 12 weeks later. Approximately every 8 weeks, users will be asked to complete a short questionnaire about their experience with Lumosity. This questionnaire will be accessed via email. Participants will be asked to train 5 days a week for 20-30 minutes per day, but are free to play as much or a little as they choose. Community associates at the sites will be encouraged to host group training sessions, giving the seniors a chance to gather and complete their training together, share their experiences, and get any help they may need. In addition, sites will have the option of hosting 1-2 focus groups with participants and researchers from Lumos Labs. The focus groups will be an opportunity to give and receive direct feedback about Lumosity, and get any questions answered by the researchers.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants must be cognitively stable older adult volunteers(over 55 years of age)
Key inclusion criteria (5 listed)
- 55 years of age or older
- English-speaker
- Cognitively stable (i.e., without a known diagnosis that may affect cognitive abilities)
- Regular access to and ability to use a computer or mobile device with Internet connectivity.
Key exclusion criteria (5 listed)
- Under 55 years of age
- Have a current diagnosed cognitive or neuropsychological condition
- Are taking medication that may impede cognitive functioning
- Anticipate a dosage change in medication that may affect cognitive functioning during the course of the study (24 weeks)
- Have other conditions or problems that may preclude regular computer usage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Usability - as measured by self-report feedback surveys
Time frame: Change from Baseline - collected at baseline, 3 months and 6 months
Using self-report surveys administered to participants at baseline, 3 months and 6 months, investigators will calculate a usability score of Lumosity.
3 secondary outcomes
User Engagement - as measured by number of unique days played
Time frame: 6 months
Change from baseline on the Lumosity Performance Index (LPI)
Time frame: Change from Baseline - collected at baseline and 6 months
Change from baseline on the Brain Performance Test (BPT)
Time frame: Change from Baseline - collected at baseline, 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
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Screening Protocol
Pain
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.
Glenn Morrison, PhD principal investigator
Lumos Labs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by Lumos Labs, Inc. at 1 site in United States.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 25 May 2017. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Usability - as measured by self-report feedback surveys (time frame: Change from Baseline - collected at baseline, 3 months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2017.