Executive FunctionNCT03638882
Cognitive Reserve and Second Language Acquisition
A study testing Duolingo and BrainHQ in people with Executive Function, run by Rotman Research Institute at Baycrest at 1 site in Canada.
Trial summary
Bilingualism has been shown to have a strong protective effect against dementia, delaying the diagnosis of Alzheimer's disease by up to 4 years. The purpose of the study is to test whether learning a second language using Duolingo software could improve cognitive functions in older adults. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Executive Function
- What is being tested?
- Duolingo and BrainHQ
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2018to 1 Oct 2020
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Participants must have normal vision and hearing.
- Participants must be able to travel to Baycrest by personal or study-arranged automobile, or public transportation.
- Participants must be monolingual native English speakers.
- Participants must be willing to provide informed consent.
- Participants must have daily access to a smartphone/mobile device.
- Have not previously studied Spanish formally, nor any other language in the past 10 years.
Who cannot join
- have a neurological disorder.
- meet DSM-IV-TR criteria for Axis I mood, anxiety, or psychotic or substance abuse disorders.
- Fluent in more than one language.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Baycrest Health Sciences
Toronto, Ontario, M6A 2E1
Jed Meltzer, Ph.D., 416-785-2500 ext. 2117, jmeltzer@research.baycrest.org
About this study
Official title: Boosting Cognitive Reserve Through Adult Second Language Acquisition With Duolingo
Bilingualism has been shown to have a strong protective effect against dementia, delaying the diagnosis of Alzheimer's disease by up to 4 years. The purpose of the study is to test whether learning a second language using Duolingo software could improve cognitive functions in older adults.
Read the detailed description
This study is a 3-arm, randomized controlled trial. The primary objective of the study is to test the impact of second language acquisition through short-term use of the Duolingo app on cognitive functioning, particularly executive function in older adults compared to a brain training application.
- Conditions
- Executive Function
- Being tested
- Duolingo, BrainHQ, Passive Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuolingoBehavioural
Will learn Spanish using the commercially available Duolingo application. It is a computerized language training program.
BrainHQBehavioural
Will use the commercially available Posit Science product Brain HQ. Brain HQ is a computerized adaptive cognitive brain training program.
Passive ControlBehavioural
No Intervention.
| Study group | Role | What they receive |
|---|---|---|
| Duolingo Spanish Course | Experimental | 30 minutes each day, 5 days a week for 16 weeks. Total of 40 hours. Receives: Behavioral: Duolingo |
| BrainHQ | Active comparator | 30 minutes each day, 5 days a week for 16 weeks. Total of 40 hours. Receives: Behavioral: BrainHQ |
| Passive Control | Placebo comparator | No intervention. Receives: Behavioral: Passive Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in working memory, n-back
Working memory assessed by the n-back test
Measured: change from baseline to 16 weeks
Change in inhibitory Control, Simon task
Inhibitory control assessed by the Simon task
Measured: change from baseline to 16 weeks
Change in inhibitory Control, DKEFS
DKEFS Colour Word Interference
Measured: change from baseline to 16 weeks
Secondary outcomes (4)
Change in attention abilities
Attention assessed by the Test of Everyday Attention (TEA)
Measured: change from baseline to 16 weeks
Change in language abilities
Winterlight designed battery assessing paragraph reading and recall, picture description and object naming.
Measured: change from baseline to 16 weeks
change in verbal fluency
semantic and phonological fluency tasks
Measured: change from baseline to 16 weeks
executive function assessed by trailmaking test
Trails B implemented on tablet
Measured: change from baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start1 Aug 2018
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Executive FunctionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rotman Research Institute at Baycrest
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Principal investigator, Jed A. Meltzer, Ph.D, Rotman Research Institute at Baycrest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638882
- Sponsor's protocol ID
- I2P2-2-00140
- Status last verified
- Sep 2019
- First submitted
- 4 Jul 2018
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosting Cognitive Reserve Through Adult Second Language Acquisition With Duolingo
- ClinicalTrials.gov ID
- NCT03638882
- Acronym / sponsor ID
- I2P2-2-00140
- Conditions
- Executive Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Rotman Research Institute at BaycrestUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 20 Aug 2018 (actual)
- 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.
Bilingualism has been shown to have a strong protective effect against dementia, delaying the diagnosis of Alzheimer's disease by up to 4 years. The purpose of the study is to test whether learning a second language using Duolingo software could improve cognitive functions in older adults.
Detailed description
This study is a 3-arm, randomized controlled trial. The primary objective of the study is to test the impact of second language acquisition through short-term use of the Duolingo app on cognitive functioning, particularly executive function in older adults compared to a brain training application.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Duolingo Spanish Course | Experimental | Behavioral: Duolingo30 minutes each day, 5 days a week for 16 weeks. Total of 40 hours. |
| BrainHQ | Active comparator | Behavioral: BrainHQ30 minutes each day, 5 days a week for 16 weeks. Total of 40 hours. |
| Passive Control | Placebo comparator | Behavioral: Passive ControlNo intervention. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Participants must have normal vision and hearing.
- Participants must be able to travel to Baycrest by personal or study-arranged automobile, or public transportation.
- Participants must be monolingual native English speakers.
- Participants must be willing to provide informed consent.
- Participants must have daily access to a smartphone/mobile device.
Key exclusion criteria (3 listed)
- have a neurological disorder.
- meet DSM-IV-TR criteria for Axis I mood, anxiety, or psychotic or substance abuse disorders.
- Fluent in more than one language.
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 |
|---|---|---|
| DuolingoWill learn Spanish using the commercially available Duolingo application. It is a computerized language training program. | Behavioural | Duolingo Spanish Course |
| BrainHQWill use the commercially available Posit Science product Brain HQ. Brain HQ is a computerized adaptive cognitive brain training program. | Behavioural | BrainHQ |
| Passive ControlNo Intervention. | Behavioural | Passive Control |
Primary outcome
Change in working memory, n-back
Time frame: change from baseline to 16 weeks
Working memory assessed by the n-back test
Change in inhibitory Control, Simon task
Time frame: change from baseline to 16 weeks
Inhibitory control assessed by the Simon task
Change in inhibitory Control, DKEFS
Time frame: change from baseline to 16 weeks
DKEFS Colour Word Interference
4 secondary outcomes
Change in attention abilities
Time frame: change from baseline to 16 weeks
Change in language abilities
Time frame: change from baseline to 16 weeks
change in verbal fluency
Time frame: change from baseline to 16 weeks
executive function assessed by trailmaking test
Time frame: change from baseline to 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duolingo and BrainHQ in people with Executive Function, run by Rotman Research Institute at Baycrest at 1 site in Canada.
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 6 inclusion and 3 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 19 Sep 2019. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
Contact Jed Meltzer, Ph.D. (416-785-2500 ext. 2117, jmeltzer@research.baycrest.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in working memory, n-back (time frame: change from baseline to 16 weeks). The study lists 3 primary outcomes in all. 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 19 Sep 2019.