This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Compression Headphone 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04882709
Recruitment Status : Terminated (No reliable differences across conditions, unacceptable test-retest reliability)
First Posted : May 12, 2021
Last Update Posted : October 6, 2021
Sponsor:
Collaborator:
Sonova Canada Inc.
Information provided by (Responsible Party):
Sonova AG

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The stimuli consist of speech in quiet, speech in noise, reverberant speech, and music recorded with different hearing aid settings, post-processed for headphone presentation and incorporated in an online sound survey. Participants will receive tablets and headphones to conduct a sound quality rating at home. The survey will involve a training session and within-subject repeated measures. Stimuli will be randomized.

Condition or disease Intervention/treatment Phase
Hearing Loss Device: Receiver-in-canal hearing aid 1 default Device: Receiver-in-canal hearing aid 2 Device: Receiver-in-canal hearing aid 1 strategy 1 Device: Receiver-in-canal hearing aid 1 strategy 2 Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Using Headphone Presentation to Investigate Compression Strategy Modifications in Hearing Aids for Moderate-to-severe Hearing Loss
Actual Study Start Date : May 10, 2021
Actual Primary Completion Date : September 2, 2021
Actual Study Completion Date : September 2, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Receiver-in-canal hearing aid 1 default
Receiver-in-canal hearing aid with current default compression strategy
 Device: Receiver-in-canal hearing aid 1 default
A receiver-in-canal hearing aid developed by the Study Sponsor used with the default settings as specified in the Study Sponsor's fitting software.
Active Comparator: Receiver-in-canal hearing aid 2
Receiver-in-canal hearing aid from a different manufacturer with default compression strategy
 Device: Receiver-in-canal hearing aid 2
A receiver-in-canal hearing aid developed by another hearing aid manufacturer used with the default settings as specified in the manufacturer's fitting software.
Experimental: Receiver-in-canal hearing aid 1 strategy 1
Receiver-in-canal hearing aid with modified compression strategy 1
 Device: Receiver-in-canal hearing aid 1 strategy 1
A receiver-in-canal hearing aid developed by the Study Sponsor used with a modified compression strategy that is expected to improve the sound quality.
Experimental: Receiver-in-canal hearing aid 1 strategy 2
Receiver-in-canal hearing aid with modified compression strategy 2
 Device: Receiver-in-canal hearing aid 1 strategy 2
A receiver-in-canal hearing aid developed by the Study Sponsor used with a modified compression strategy that is expected to improve the sound quality.
No Intervention: No device
Stimuli recordings without hearing aid


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Sound quality rating [ Time Frame: 1 hour ]
    The sound quality rating will be conducted via an online questionnaire that contains sound samples participants listen to and rate subsequently. Dimensions rated are: Overall Preference, Reverberation, Sound Source Localization, Sound Source Separation, and Timbral Balance.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (18-99 years) with ≥3 months hearing aid experience
  • binaural, symmetric, sensorineural N3 to N4 hearing loss
  • able to use Android interface and receive a video call on phone/computer
  • fluent in English

Exclusion Criteria:

  • children/teenagers
  • normal hearing or hearing loss exceeding N4 by 10dB
  • cannot wear over-ear headphones
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04882709


Locations
Layout table for location information
Canada, Ontario
Sonova Innovation Centre Toronto
Mississauga, Ontario, Canada, L5L1J3
Sponsors and Collaborators
Sonova AG
Sonova Canada Inc.
Investigators
Layout table for investigator information
Principal Investigator: Jinyu Qian, PhD Sonova Canada Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Sonova AG
ClinicalTrials.gov Identifier: NCT04882709    
Other Study ID Numbers: 365
First Posted: May 12, 2021    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases