Remote Microphone Candidacy Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03897634|
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : September 9, 2019
Despite improvements in digital hearing aid technology, many hearing aid users continue to report difficulty understanding speech in challenging listening environments. Remote microphones have been shown to provide benefit in the most common of these challenging listening environments: distant speakers, background noise, and reverberation. Despite demonstrated benefit, there is a low rate of remote microphone use among adult hearing aid users. One reason for low uptake may be an uncertainty among hearing healthcare providers and potential users regarding expected clinically relevant benefit. This clinical trial will attempt the following:
- To describe the range of remote microphone benefit among adults with mild-to-moderate sensorineural hearing loss
- To determine specific individual factors beyond the audiogram that are associated with greater benefit from remote microphones
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss, Sensorineural||Device: Remote Microphone||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Within-subject design: Baseline assessments compared to post-trial results.|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial of Roger Adaptive Digital Technology|
|Actual Study Start Date :||August 30, 2019|
|Estimated Primary Completion Date :||February 15, 2020|
|Estimated Study Completion Date :||March 15, 2020|
Experimental: Experiences Hearing Aid user
Single arm study, all participants in this arm. Participants will be experienced hearing aid users.
Device: Remote Microphone
Experienced hearing aid users will be trained on and use a remote microphone for 30 days. Pre- and Post- measures will be taken to determine benefit. Participant characteristics will also be assessed (such as self-efficacy) to explore personality factors that may contribute to benefit from devices.
Other Name: Roger Select
- Change in Abbreviated Profile of Hearing Aid Benefit (APHAB) [ Time Frame: Change from baseline to final appointment will be assessed. Participants will take a baseline at the start of the trial and then complete post-intervention at the end of the 30-day trial. ]Self assessment, disability based inventory that is used to document outcomes of hearing aid fittings. The APHAB uses a percentile scale (Percent of Problems). This measure has 4 subscales: Ease of communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV). A lower score indicates a better outcome. We will look at both the global change (defined as EC, RV, and BN scores improving by at least 5 points each) and individual subscales (For EC, RV, or BN a change in 22 points is considered significant and for AV a change of 31 points is needed to be considered significant).
- Change in Speech, Spatial, and Qualities of Hearing (SSQ) [ Time Frame: Change from baseline to final appointment will be assessed. Participants will take a baseline at the start of the trial and then complete post-intervention at the end of the 30-day trial. ]Questionnaire, clinical patient interview design where participants respond on a scale of 0 to 10, with 10 indicating perfect hearing ability and 0 indicating complete inability.There are 3 subscales calculated by averaged the responses to the questions for each subscale. A change of 2 points is considered a moderate effect with increase in score indicating improvement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897634
|Contact: Kendra Marks, Au.D.||firstname.lastname@example.org|
|Contact: Pamela Souza, PhDemail@example.com|
|United States, Illinois|
|Evanston, Illinois, United States, 60208|
|Contact: Kendra Marks 847-467-0897 firstname.lastname@example.org|
|Principal Investigator:||Pamela Souza, PhD||Northwestern University|