Hearing Impairment Clinical Trial
— PPTOfficial title:
The Performance-Perceptual Test as a Counseling Tool
Verified date | October 2014 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
The purpose of the study is to determine whether a new test of ability to understand speech in noise and an associated counseling program can improve hearing aid satisfaction. Participants complete routine hearing tests, some hearing-related questionnaires and the new speech test. One group of participants receives the new form of counseling, the second group does not. Hearing aid satisfaction following 10 weeks hearing aid use is compared across the groups.
Status | Completed |
Enrollment | 74 |
Est. completion date | November 2008 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 45 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Mild-to-moderate symmetrical sensorineural hearing loss - Current users of binaural hearing aids Exclusion Criteria: - Conductive hearing impairment or other otological pathology - A score less than age-based norms on the Mini Mental State Examination - Asymmetrical hearing loss - No prior use of hearing aids |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
Country | Name | City | State |
---|---|---|---|
United States | VA Medical Center, Portland | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Saunders GH, Forsline A. Hearing-aid counseling: comparison of single-session informational counseling with single-session performance-perceptual counseling. Int J Audiol. 2012 Oct;51(10):754-64. Epub 2012 Jul 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Psychosocial Impact of Assistive Devices Scale (PIADS) | PIADS: The PIADS measures the psychosocial impact of any assistive device(s). Here that is a hearing aid. The PIADS is a 26-item self-rating scale. The user rates each item on a seven-point scale that ranges from negative 3 (maximum negative impact) to positive 3 (maximum positive impact). The midpoint, zero, indicates no impact or no perceived change resulting from device use. It measures three quality-of-life domains: (1) Adaptability that reflects the inclination or motivation to participate socially and take risks; (2) Competence that reflects perceived functional capability, independence, and performance; and (3) Self-esteem that reflects self-confidence, self esteem, and emotional well-being. | Day 70 (end of study) only | No |
Secondary | Hearing Handicap Inventory (HHI) | HHI: The HHI for the elderly is for individuals over age 65 years; the HHI for adults is for individuals aged 65 years and younger. Both are 25-item questionnaires that assess the social and emotional consequences of hearing loss. The versions differ in the wording of three questions. Items are answered on a scale of Yes (4 points), Sometimes (2 points), and No (0 points) with higher scores indicating greater reported hearing handicap. Scores can range from 0 (no handicap) to 100 (maximum handicap). | Day 70 (end of study) | No |
Secondary | Abbreviated Profile of Hearing Aid Benefit (APHAB) | APHAB: The APHAB is a 24-item questionnaire that documents hearing difficulties in specified listening situations. Items are answered on a seven-point scale from ' Always ' to ' Never ' with higher scores indicating greater reported hearing disability. The questionnaire has four subscales: Ease of communication, Reverberation, Background noise, and Aversiveness, from which a global score is computed by averaging the Ease of communication, Reverberation, and Background noise scale scores. Questions are answered for unaided and aided listening. By subtracting aided scores from unaided scores a measure of reported aided benefit is obtained. Scores can range from 0 (no disability) to 99 (maximum disability). | Day 70 (end of study) | No |
Secondary | International Outcome Inventory for Hearing Aids (IOI-HA) | The IOI-HA is a seven-item questionnaire for which hearing-aid use, hearing-aid benefit, residual activity limitation, hearing-aid satisfaction, residual participation restriction, impact on others, and quality of life are rated on a five-point scale. An overall IOI-HA score is generated by averaging responses to all seven items. Higher scores reflect better self-reported outcome. Scores can range from 7 (poorest outcome) to 35 (best outcome). | Day 70 (end of study) | No |
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