Clinical trial NCT00126113: The Performance-Perceptual Test as a Counseling Tool
Official title: The Performance-Perceptual Test as a Counseling Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Impairment
Keywords: Audiologic rehabilitation
Counseling
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-08-02
Enrollment: 74
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: Hearing aid dissatisfaction continues to be disappointingly high, even though hearing aid technology has improved dramatically over the last 10 years or so. Unfortunately, the results of most commonly used self-report measures cannot be directly compared with the results from performance measures since the modes of testing are very different. Thus, it is hard for clinicians to reconcile data from individuals reporting more handicap or less hearing aid satisfaction than would be expected from their performance.

In this study, the investigators use a test known as the Performance-Perceptual Test (PPT) to determine whether simple counseling based upon discussion of PPT results can be used to better align perceived and measured ability to understand speech-in-noise; and, more importantly, whether such counseling can decrease reported handicap and improve hearing aid satisfaction.

Hearing aid users complete the PPT for aided and unaided listening, along with standardized questionnaires measuring reported auditory disability, handicap and hearing aid satisfaction. Following this, subjects are randomly assigned to one of two groups. Subjects in Group 1 receive counseling from the experimenter in the form of an explanation and discussion of their PPT results. Subjects in Group 2 also participate in a discussion with the experimenter, but it does not include an explanation of the PPT. Two weeks after enrollment in the study subjects complete a second set of questionnaires. Ten weeks after study enrollment subjects return to the laboratory to rerun the test battery. The impact of the counseling upon PPT values, reported handicap and hearing aid satisfaction and benefit will be compared across the two groups.

Eligibility criteria: 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

Primary outcomes:
measure: Psychosocial Impact of Assistive Devices Scale (PIADS)
timeFrame: Day 70 (end of study) only
Secondary outcomes:
measure: Hearing Handicap Inventory (HHI)
timeFrame: Day 70 (end of study)
measure: Abbreviated Profile of Hearing Aid Benefit (APHAB)
timeFrame: Day 70 (end of study)
measure: International Outcome Inventory for Hearing Aids (IOI-HA)
timeFrame: Day 70 (end of study)
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Medical Center, Portland
state: Oregon
Study officials:
affiliation: VA Medical Center, Portland
name: Gabrielle H Saunders
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.3109/14992027.2012.699200. Epub 2012 Jul 19.