Focus of the Study is to Promote Healthy HearingNoisyCityNCT02946567
Game to Improve Hearing Health Care Outcomes
A study testing Noisy City information about hearing health care and Generic Game in people with Focus of the Study is to Promote Healthy Hearing, run by Photozig, Inc. at 1 site in United States.
Trial summary
The investigators are studying the educational potential of games, with the goal of developing a game to improve learning and promote healthy hearing behaviors. The project is looking for adolescents and young adults that play games to share their experience and learning from playing games. Read more about this study
- Who is it for?
- Ages 13 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus of the Study is to Promote Healthy Hearing
- What is being tested?
- Noisy City information about hearing health care and Generic Game
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Mar 2017
- 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 13 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants have to be between the ages of 13 and 20 years of age (either gender).
- Participants who are between the ages of 13 and 17 years of age must have a willing and able parent or legal guardian who permits them to participate.
- Participants must have Internet access, an email address (or be able to use parent's/legal guardian's email address), and agree to play a game (random assignment to a group with a different game).
Who cannot join
- Participants will be excluded if they are cognitively impaired, have any serious medical problem that may interfere with their ability to engage with the online game.
- Those who are not able to read/follow written instructions and individuals with an excessive addiction to games will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Photozig, Inc.
Moffett Field, California, 94035-0128
About this study
The investigators are studying the educational potential of games, with the goal of developing a game to improve learning and promote healthy hearing behaviors.
The project is looking for adolescents and young adults that play games to share their experience and learning from playing games.
Read more
The investigators ask participants to fill out an enrollment form/informed consent, complete surveys on healthy hearing habits, and play a game provided by the project.
This projects aims the development and evaluation of a game to educate teenagers and young adults about noise-induced hearing loss, enhance knowledge about hearing, and promote healthy hearing behaviors with the potential to improve hearing health care.
- Being tested
- Noisy City information about hearing health care, Generic Game
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noisy City information about hearing health careOther
Participants will play the game Noisy City, which contains information about hearing health care.
Generic GameOther
Participants will play a generic game without any particular information about hearing health care.
| Study group | Role | What they receive |
|---|---|---|
| Noisy City | Experimental | Participant will play the Noisy City game developed by this project. Receives: Other: Noisy City information about hearing health care |
| Control | Placebo comparator | Participant will play a generic game. Receives: Other: Generic Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge, Attitudes, and Intended Behavior Questionnaire about hearing health care
This instrument has been used to evaluate the effectiveness of past hearing loss prevention programs funded by the National Institute of Health. It contains questions on knowledge, attitudes, and intended behavior related to hearing health care. Although there are questions in different domains, the instrument consolidates the overall perception of participant on hearing health care.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of the Study is to Promote Healthy HearingStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Photozig, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Bruno Kajiyama, Photozig, Inc.
- Investigators
- Bruno Kajiyama, MS, Principal investigator, Photozig, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946567
- Sponsor's protocol ID
- Pz-A105a
- Other IDs
- R44DC013114
- Acronym
- NoisyCity
- Status last verified
- Oct 2017
- First submitted
- 24 Oct 2016
- Last updated
- 5 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Game to Improve Hearing Health Care Outcomes
- ClinicalTrials.gov ID
- NCT02946567
- Acronym / sponsor ID
- NoisyCity / Pz-A105a
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Photozig, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Sep 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 27 Oct 2016 (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 investigators are studying the educational potential of games, with the goal of developing a game to improve learning and promote healthy hearing behaviors.
The project is looking for adolescents and young adults that play games to share their experience and learning from playing games.
The investigators ask participants to fill out an enrollment form/informed consent, complete surveys on healthy hearing habits, and play a game provided by the project.
This projects aims the development and evaluation of a game to educate teenagers and young adults about noise-induced hearing loss, enhance knowledge about hearing, and promote healthy hearing behaviors with the potential to improve hearing health care.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noisy City | Experimental | Other: Noisy City information about hearing health careParticipant will play the Noisy City game developed by this project. |
| Control | Placebo comparator | Other: Generic GameParticipant will play a generic game. |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Participants have to be between the ages of 13 and 20 years of age (either gender).
- Participants who are between the ages of 13 and 17 years of age must have a willing and able parent or legal guardian who permits them to participate.
- Participants must have Internet access, an email address (or be able to use parent's/legal guardian's email address), and agree to play a game (random assignment to a group with a different game).
Key exclusion criteria (2 listed)
- Participants will be excluded if they are cognitively impaired, have any serious medical problem that may interfere with their ability to engage with the online game.
- Those who are not able to read/follow written instructions and individuals with an excessive addiction to games will be excluded.
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 |
|---|---|---|
| Noisy City information about hearing health careParticipants will play the game Noisy City, which contains information about hearing health care. | Other | Noisy City |
| Generic GameParticipants will play a generic game without any particular information about hearing health care. | Other | Control |
Primary outcome
Knowledge, Attitudes, and Intended Behavior Questionnaire about hearing health care
Time frame: 9 weeks
This instrument has been used to evaluate the effectiveness of past hearing loss prevention programs funded by the National Institute of Health. It contains questions on knowledge, attitudes, and intended behavior related to hearing health care. Although there are questions in different domains, the instrument consolidates the overall perception of participant on hearing health care.
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 5 Oct 2017.
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.
Bruno Kajiyama, MS principal investigator
Photozig, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noisy City information about hearing health care and Generic Game in people with Focus of the Study is to Promote Healthy Hearing, run by Photozig, 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 3 inclusion and 2 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 5 Oct 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. 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?
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?
Knowledge, Attitudes, and Intended Behavior Questionnaire about hearing health care (time frame: 9 weeks). 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 5 Oct 2017.