Last reviewed · How we verify

NCT03850678

Restoration of Spectral Resolution With Hearing-aid Amplification

Completed NA Results posted Last updated 14 January 2025
What this trial tests

NA trial testing Hearing Aid in Hearing Loss in 209 participants. Completed in 30 November 2023.

Timeline
2 April 2019
Primary endpoint
30 November 2023
30 November 2023

Quick facts

Lead sponsorUniversity of Nebraska Lincoln
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designfactorial
Maskingsingle
Primary purposetreatment
Enrollment209
Start date2 April 2019
Primary completion30 November 2023
Estimated completion30 November 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Nebraska Lincoln

Who can join

Adults 40 to 75, any sex, with Hearing Loss. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Spectral Resolution Primary · Each test was approximately 10 minutes and was completed after each experimental manipulation

Measure of spectral resolution (Q10) obtained from the fast psychophysical tuning curve test. For this study, Q10 was computed as the target frequency divided by the bandwidth of the tuning curve (10 dB above the threshold at the tip of the tuning curve test). Higher numbers on this scale indicate sharper (better) tuning. The lower limit for this scale is 0 and there is no upper limit.

Instant
GroupValue95% CI
Hearing Aid Group3.5± 2.2
Fast
GroupValue95% CI
Hearing Aid Group3.3± 1.9
Slow
GroupValue95% CI
Hearing Aid Group3.2± 1.6
4 Channels
GroupValue95% CI
Hearing Aid Group2.8± 1.2
8 Channels
GroupValue95% CI
Hearing Aid Group2.5± 1.7
16 Channels
GroupValue95% CI
Hearing Aid Group3.5± 1.1
Unaided
GroupValue95% CI
Hearing Aid Group2.7± 1.7
Normal Hearing3.9± 2.0
Aided
GroupValue95% CI
Hearing Aid Group3.2± 1.1
Speech Recognition Primary · Each test was approximately 10 minutes and was completed after each experimental manipulation

measure of spatial release from masking (dB) for a masker presented at 70 dB SPL.

unaided
GroupValue95% CI
Normal Hearing6.6± 5.1
Hearing Aid4.5± 1.9
4 channels
GroupValue95% CI
Hearing Aid4.0± 3.2
16 channels
GroupValue95% CI
Hearing Aid3.7± 2.8
Working Memory Secondary · Each test was approximately 30 minutes and was completed only once per subject.

Measure of working memory (correctly repeated words from the reading span test). The minimum (poorer) and maximum (better) values are 0 and 57, respectively.

GroupValue95% CI
Normal Hearing23.6± 6.8
Hearing Aid20.1± 7.4

Sponsor's own description

The objective of this study protocol is to determine the efficacy of using aided measures of spectral resolution to set the dynamic range of hearing with hearing-aid amplification. Measures of spectral resolution will be obtained, as will measures of speech recognition.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Hearing Aid

Trials testing the same drug.

Other recruiting trials for Hearing Loss

Currently open trials in the same condition.

Other University of Nebraska Lincoln trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03850678.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing