NCT05292534

Brief Summary

Participants with hearing loss and Tinnitus will wear hearing aids with amplification-only or with an added sound, and have their tinnitus level evaluated before and after intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 23, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
10 months until next milestone

Results Posted

Study results publicly available

July 5, 2024

Completed
Last Updated

July 5, 2024

Status Verified

April 1, 2024

Enrollment Period

1.3 years

First QC Date

March 9, 2022

Results QC Date

April 24, 2024

Last Update Submit

July 1, 2024

Conditions

Hearing Loss, SensorineuralTinnitus

Outcome Measures

Primary Outcomes (1)

  • Tinnitus Functional Index Evaluation (TFI)

    Tinnitus Functional Index (TFI) questionnaire results, ranging from 0 to 100, with higher numbers indicating more severe (worse) Tinnitus interference in the person's quality of life.

    TFI collected before intervention to serve as a baseline. TFI change from baseline will be assessed after each study condition, which will last 4 weeks/each.

Study Arms (3)

Amplification-only

ACTIVE COMPARATOR

Hearing aid will be fit to prescribed participant hearing loss.

Device: hearing aid amplification

Amplification with added sound

ACTIVE COMPARATOR

Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated on the hearing aid.

Device: hearing aid amplification with an added sound

No intervention

NO INTERVENTION

Participants will return to their original unaided state.

Interventions

hearing aid amplificationDEVICE

Hearing aid will be fit to prescribed participant hearing loss.

Amplification-only
hearing aid amplification with an added soundDEVICE

Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated.

Amplification with added sound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hearing loss
  • candidate for hearing aid amplification
  • Bothersome chronic tinnitus (3 months+)

You may not qualify if:

  • age less than 18 years
  • normal hearing
  • tinnitus presence for less than 3 months
  • tinnitus not bothersome enough to warrant intervention
  • non hearing aid candidates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The State University of New York at Buffalo

Buffalo, New York, 14203, United States

Location

Related Publications (2)

  • Meikle MB, Henry JA, Griest SE, Stewart BJ, Abrams HB, McArdle R, Myers PJ, Newman CW, Sandridge S, Turk DC, Folmer RL, Frederick EJ, House JW, Jacobson GP, Kinney SE, Martin WH, Nagler SM, Reich GE, Searchfield G, Sweetow R, Vernon JA. The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus. Ear Hear. 2012 Mar-Apr;33(2):153-76. doi: 10.1097/AUD.0b013e31822f67c0.

    PMID: 22156949BACKGROUND

  • Henry JA, Griest S, Thielman E, McMillan G, Kaelin C, Carlson KF. Tinnitus Functional Index: Development, validation, outcomes research, and clinical application. Hear Res. 2016 Apr;334:58-64. doi: 10.1016/j.heares.2015.06.004. Epub 2015 Jun 12.

    PMID: 26074306BACKGROUND

MeSH Terms

Conditions

Hearing Loss, SensorineuralTinnitus

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Ieda Ishida
Organization
Sonova
ieda.ishida@sonova.com
6472847562

Study Officials

  • Wei Sun, Ph.D.

    State University of New York at Buffalo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2022

First Posted

March 23, 2022

Study Start

June 1, 2022

Primary Completion

September 20, 2023

Study Completion

September 20, 2023

Last Updated

July 5, 2024

Results First Posted

July 5, 2024

Record last verified: 2024-04

Locations

US(1)