Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| State University of New York at Buffalo | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
2 groups of adults with hearing loss and chronic bothersome tinnitus and no experience with amplification will participate in a cross over intervention study with 2 conditions of 4 weeks each: 1. fit with hearing aid (HA) amplification-only, and 2. fit with HA amplification with an added sound, returning to their original unaided condition after undergoing the intervention phase.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amplification-only | Active Comparator | Hearing aid will be fit to prescribed participant hearing loss. |
|
| 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. |
|
| No intervention | No Intervention | Participants will return to their original unaided state. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hearing aid amplification | Device | Hearing aid will be fit to prescribed participant hearing loss. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wei Sun, Ph.D. | State University of New York at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The State University of New York at Buffalo | Buffalo | New York | 14203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22156949 | Background | 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. | |
| 26074306 |
Not provided
Not provided
38 participants were randomly assigned into one of two groups. Out of the 38 participants, 8 dropped out during the study. There were 2 study groups in this cross-over study, and final numbers were 15 participants in each group.
38 participants signed the consent form and met study criteria
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Amplification-only, Then Amplification With an Added Sound, Then Intervention Withdrawal | 3 study conditions (4 weeks each):
Hearing aid was fit to prescribed participant hearing loss for 4 weeks during the 1st intervention period. Then the participants wore the same study hearing aids for another 4 weeks with an added sound to the amplification setting. Then the participants returned the hearing devices to the investigator and were re-assessed 4 weeks after intervention withdrawal. |
| FG001 | Amplification With Added Sound, Then Amplification-only, Then Intervention Withdrawal | 3 study conditions (4 weeks each):
Hearing aid was fit to prescribed participant hearing loss and an added sound activated on the hearing aid and worn for 4 weeks during the 1st intervention period. Then the participants wore the same study hearing aids for another 4 weeks without the added sound to the amplification setting. Then the participants returned the hearing devices to the investigator and were re-assessed 4 weeks after intervention withdrawal. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Group 1 and Group 2 had 15 participants/each.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cross Over Design, 2 Groups of Participants | First Group: started with amplification-only as a 1st intervention, and switched to amplification+noiser Second Group: started with amplification+noiser as a 1st intervention, and switched to amplification-only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Table above present the mean age (and standard deviation) of each separate group of 15 participants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Repeated measures. Participants served as their own control. | Posted | Mean | Standard Deviation | units on a scale | 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. |
|
10 months (Between Nov 2022 until September 2023).
Safety population included all participants in this study, who experienced at least one intervention mode.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amplification-only | Hearing aid will be fit to prescribed participant hearing loss. hearing aid amplification: Hearing aid will be fit to prescribed participant hearing loss. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acquired COVID | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ieda Ishida | Sonova | 6472847562 | ieda.ishida@sonova.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 5, 2024 | Apr 18, 2024 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| hearing aid amplification with an added sound | Device | Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated. |
|
| Background |
| 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. |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 30 participants divided into 2 groups of 15 participants/each. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| TFI | 15 participants in each of the 2 groups, totaling 30 participants in the study. | Mean | Standard Deviation | points |
|
Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated on the hearing aid. hearing aid amplification with an added sound: Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated. |
| OG002 | No Intervention | Participants will return to their original unaided state. |
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 2 |
| 30 |
| EG001 | Amplification With Added Sound | Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated on the hearing aid. hearing aid amplification with an added sound: Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated. | 0 | 30 | 0 | 30 | 1 | 30 |
| EG002 | No Intervention | Participants will return to their original unaided state. | 0 | 30 | 0 | 30 | 2 | 30 |
| Ear infection after swimming | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Body ache after general incidents happening during the trial period | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment | Events were: body ache after moving furniture, body ache after falling in the bathroom at night, mouth discomfort after being stuck open at the dentist during a procedure. |
|
Not provided
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |