Hearing ScreenerNCT05848804
Hearing Screener Study
An observational study of Hearing Screener, run by Linus Health, Inc. at 1 site in United States.
Trial summary
The objective is to compare the Linus Health Hearing Screener (LHHS) to established hearing screening methods performed by a hearing specialist. We will perform an in-office speech hearing test and compare the thresholds with those measured from the iPad at a distance of 1ft with a sound pressure level (SPL) (dBA)… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Screener
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2022to 31 Dec 2023
- How long will I take part?
- 1 Year
- 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: Up to three US sites will be used in this study for enrollment. Participants will be recruited from the following clinics: nursing home, memory clinic, primary and/or specialty care in order to recruit subjects with a range of hearing functions.
Who may be able to join
- All participants must be (1) Those with a range of hearing ability but not deaf; (2) 55+ years old; (3) able to use an iPad and Apple Pencil; (4) as close to their normal hearing conditions as possible: if they wear hearing aids normally they should have them during the assessment; if not, they should not wear them; (5) able to provide written informed consent in the Institutional Review Board-approved informed consent form; (6) willing and able to comply with all study procedures as outlined in the informed consent; and (7) fluent in English.
Who cannot join
- Exclusion criteria include (1) individuals who are not able to understand or willing to comply with the directions for the administration of neuropsychological tests; (2) the presence of a major psychiatric upset such as bipolar disorder; (3) present with major medical problems such as cancer or epilepsy. Study staff will review potential participants who do not have dementia and can be approached about the study.
Trial locations and contacts
1 site in 1 country.
Russell Banks, PhD contact
United States1 site, 1 recruiting
- Recruiting
Crossover Mangement
Wake Forest, North Carolina, 27587
David Woolever, davidjwoolever@gmail.com
David Woolever
About this study
Official title: Linus Health Hearing Screening Clinical Study
The objective is to compare the Linus Health Hearing Screener (LHHS) to established hearing screening methods performed by a hearing specialist. We will perform an in-office speech hearing test and compare the thresholds with those measured from the iPad at a distance of 1ft with a sound pressure level (SPL) (dBA) meter
- Conditions
- Hearing Screener
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing Thresholds
The objective is to compare the Linus Health Hearing Screener (LHHS) to established hearing screening methods performed by a hearing specialist. We aim to perform an in-office hearing test and compare the thresholds with those measured from the iPad at a distance of 11ft with an SPL (dBA) meter. Comparing hearing test results between the LHHS and the results of a lab grade audiogram.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start22 Dec 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing ScreenerStudies 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Linus Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joyce Gomes-Osman, PhD, Study director, Linus Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848804
- Sponsor's protocol ID
- HSCS-001
- Status last verified
- Sep 2023
- First submitted
- 28 Apr 2023
- Last updated
- 28 Sep 2023
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linus Health Hearing Screening Clinical Study
- ClinicalTrials.gov ID
- NCT05848804
- Acronym / sponsor ID
- HSCS-001
- Conditions
- Hearing Screener
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Linus Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 May 2023 (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.
The objective is to compare the Linus Health Hearing Screener (LHHS) to established hearing screening methods performed by a hearing specialist. We will perform an in-office speech hearing test and compare the thresholds with those measured from the iPad at a distance of 1ft with a sound pressure level (SPL) (dBA) meter
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Up to three US sites will be used in this study for enrollment. Participants will be recruited from the following clinics: nursing home, memory clinic, primary and/or specialty care in order to recruit subjects with a range of hearing functions.
Key inclusion criteria (1 listed)
- All participants must be (1) Those with a range of hearing ability but not deaf; (2) 55+ years old; (3) able to use an iPad and Apple Pencil; (4) as close to their normal hearing conditions as possible: if they wear hearing aids normally they should have them during the assessment; if not, they should not wear them; (5) able to provide written informed consent in the Institutional Review Board-approved informed consent form; (6) willing and able to comply with all study procedures as outlined in the informed consent; and (7) fluent in English.
Key exclusion criteria (1 listed)
- Exclusion criteria include (1) individuals who are not able to understand or willing to comply with the directions for the administration of neuropsychological tests; (2) the presence of a major psychiatric upset such as bipolar disorder; (3) present with major medical problems such as cancer or epilepsy. Study staff will review potential participants who do not have dementia and can be approached about the study.
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
Hearing Thresholds
Time frame: 1 Year
The objective is to compare the Linus Health Hearing Screener (LHHS) to established hearing screening methods performed by a hearing specialist. We aim to perform an in-office hearing test and compare the thresholds with those measured from the iPad at a distance of 11ft with an SPL (dBA) meter. Comparing hearing test results between the LHHS and the results of a lab grade audiogram.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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.
Russell Banks, PhD contact
Joyce Gomes-Osman, PhD study director
Linus Health
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 Hearing Screener, run by Linus Health, 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 1 inclusion and 1 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 28 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact William I Morrow (9196141515, imorrow@linus.health), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing Thresholds (time frame: 1 Year). 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 28 Sep 2023.