Investigation of Anatomical Correlates of Speech Discrimination

Sensorineural Hearing Loss Clinical Trial

Official title:

Investigation of Anatomical Correlates of Speech Discrimination

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01781039
• Other study ID #: 00652
• Status: Recruiting
• Start date: January 2013
• Est. completion date: August 2026

Study information

• Verified date: December 2022
• Source: Steward St. Elizabeth's Medical Center of Boston, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Understanding speech is essential for good communication. Individuals with hearing loss and poor speech discrimination often have little success with hearing aids because amplifying sound improves audibility, but not clarity of the speech signal. The purpose of this study is to determine the relative importance of the sensory cells of the inner ear and auditory neurons on speech discrimination performance in quiet and in noise. This information may be used as a predictor of hearing aid benefit. The investigators expect to find decreased speech understanding ability resulting from both loss of sensory cells and the loss of auditory neurons.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1652
• Est. completion date: August 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Normal hearing to moderate sensorineural hearing loss

• Sufficient English proficiency to complete speech discrimination testing in English

Exclusion Criteria:

• Hearing loss less than a 45 dB HL pure tone average (average hearing thresholds at 500, 1000 and 2000 Hz)

• Conductive hearing loss

• Neurodegenerative disease

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss

Intervention

Device:
• Hearing Aid fitting
Subjects with hfPTAs ranging from 0-55 dB HL will be recruitedwith 100 persons self-reporting difficulty HIN (> 50% of the time), and 100 persons reporting little difficulty HIN (< 50% of the time) will be randomly assigned to one of five groups (n = 200) based on enabled HA features using an online random assignment tool. Unaided HIQ and HIN assessments will be conducted in the sound field, and baseline DPOAE and CAP assessments will be measured. Subjects will be fit with binaural premium level receiver-in-the canal HAs (Phonak B90 or equivalent model at the start of the study) with 56 dB SPL gain receivers, using closed domes, and programmed to NAL-NL2 target gain, and randomly assigned to the groups.

Locations

Country	Name	City	State
United States	Steward St. Elizabeth's Medical Center	Brighton	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Steward St. Elizabeth's Medical Center of Boston, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bramhall N, Ong B, Ko J, Parker M. Speech Perception Ability in Noise is Correlated with Auditory Brainstem Response Wave I Amplitude. J Am Acad Audiol. 2015 May;26(5):509-517. doi: 10.3766/jaaa.14100. — View Citation

Hoben R, Easow G, Pevzner S, Parker MA. Outer Hair Cell and Auditory Nerve Function in Speech Recognition in Quiet and in Background Noise. Front Neurosci. 2017 Apr 7;11:157. doi: 10.3389/fnins.2017.00157. eCollection 2017. — View Citation

Parker MA. Identifying three otopathologies in humans. Hear Res. 2020 Dec;398:108079. doi: 10.1016/j.heares.2020.108079. Epub 2020 Sep 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regression analysis	Regression analysis will be used to look for a correlation between measures of sensory cell and auditory neuron survival and speech recognition performance.	June 2024

External Links

•   Peer reviewed publication
•   Peer reviewed publication
•   Peer reviewed publication