Recruiting

Observational Study

Sponsor:

Linus Health, Inc.

Code:

NCT05848804

Conditions

Hearing Screener

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Study Details

Brief 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) meter

Conditions

Hearing Screener

Study ID

NCT05848804

Start date

Dec 22, 2022

Status verified date

Sep, 2023

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Hearing Thresholds [ Time Frame: 1 Year ]

Central Contacts and Locations

Central contacts

William I Morrow

9196141515imorrow@linus.health

Locations

Crossover Mangement

Recruiting

Wake Forest, North Carolina, United States, 27587

Contacts

David Woolever

davidjwoolever@gmail.com

Principal Investigator:

David Woolever

More Information

Sponsor

Linus Health, Inc.

Last update posted

Sep 28, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Linus Health, Inc. on 2023-09-28.