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Remote Microphone Candidacy Study

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ClinicalTrials.gov Identifier: NCT03897634
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
Phonak AG, Switzerland
Information provided by (Responsible Party):
Pamela Souza, Northwestern University

Brief Summary:

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:

  1. To describe the range of remote microphone benefit among adults with mild-to-moderate sensorineural hearing loss
  2. 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

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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)
Primary Purpose: Treatment
Official Title: Clinical Trial of Roger Adaptive Digital Technology
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : November 15, 2019
Estimated Study Completion Date : November 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Adults age 18-85 years
  2. Speak English as their primary language
  3. Normal or corrected to normal vision
  4. Sensorineural hearing loss with pure-tone thresholds 20-85 dB HL at octave frequencies between 500 and 3000 Hz
  5. Current hearing aid wearer with at least 3 months of experience

Exclusion Criteria:

  1. Clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator places the participant at unacceptable risk if he or she were to participate in the study
  2. Participants who do not pass a cognitive screening test (e.g., MoCA)
  3. Significant history of otologic or neurologic disorders
  4. Conductive hearing loss pathology or fluctuating hearing loss

Information from the National Library of Medicine

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


Contacts
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Contact: Kendra Marks, Au.D. 847-467-0897 kendra.marks@northwestern.edu
Contact: Pamela Souza, PhD 847-467-0897 p-souza@northwestern.edu

Locations
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United States, Illinois
Northwestern University Not yet recruiting
Evanston, Illinois, United States, 60208
Contact: Kendra Marks    847-467-0897    kendra.marks@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Phonak AG, Switzerland
Investigators
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Principal Investigator: Pamela Souza, PhD Northwestern University

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Responsible Party: Pamela Souza, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03897634     History of Changes
Other Study ID Numbers: SP0053453
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Pamela Souza, Northwestern University:
Assistive Listening Device (ALD)
Hearing in Noise

Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms