Clinical Trial: The Performance-Perceptual Test as a Counseling Tool
This study is not yet open for patient recruitment.
Verified by Department of Veterans Affairs June 2005
| Sponsored by: | Department of Veterans Affairs | | Information provided by: | Department of Veterans Affairs | | ClinicalTrials.gov Identifier: | NCT00126113 | |
Purpose
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 will complete routine hearing tests, some hearing-related questionnaires and the new speech test. One group of participants will then receive the new form of counseling, a second group will not. Hearing aid satisfaction following 10 weeks hearing aid use will be compared across the groups.
| Condition | Intervention |
Hearing Impairment
| Procedure: Hearing aid outcomes following new counseling procedure
|
MedlinePlus related topics: Hearing Disorders and Deafness
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Further Study Details:
Primary Outcomes: Self-reported hearing aid use (Frequency and hours per day) at end of study participation (70 days after starting study).; Scores of hearing aid satisfaction rating scales at end of study participation (70 days after starting study).
Secondary Outcomes: Reported hearing aid benefit at end of study participation (70 days after starting study).; Reported hearing handicap at end of study participation (70 days after starting study).
Expected Total Enrollment: 80
Study start: August 2005; Expected completion: June 2007
Last follow-up: June 2007; Data entry closure: June 2007
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, we will 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 will complete the PPT for aided and unaided listening, along with standardized questionnaires measuring reported auditory disability, handicap and hearing aid satisfaction. Following this, subjects will be randomly assigned to one of two groups. Subjects in Group 1 will receive counseling from the experimenter in the form of an explanation and discussion of their PPT results. Subjects in Group 2 will also participate in a discussion with the experimenter, but it will not include an explanation of the PPT. Two weeks after enrollment in the study subjects will complete a second set of questionnaires. Ten weeks after study enrollment subjects will 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
Ages Eligible for Study: 45 Years - 65 Years, Genders Eligible for Study: Both
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. -
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00126113
Oregon Portland VA Medical Center, Portland, Oregon, 97207, United States
Sola Whitehead, CIP 503-220-8262 Ext. 52885 sola.whitehead@med.va.gov
Beverly Jefferson 503-220-8262 Ext. 52900 Beverly.jefferson@med.va.gov
Study chairs or principal investigators
Gabrielle H Saunders, Ph.D., Principal Investigator, National Center for Rehabilitative Auditory Research at Portland VA Medical Center
More Information
Publications
Saunders GH, Forsline A, Fausti SA. The performance-perceptual test and its relationship to unaided reported handicap. Ear Hear. 2004 Apr;25(2):117-26.
Saunders GH, Cienkowski KM. A test to measure subjective and objective speech intelligibility. J Am Acad Audiol. 2002 Jan;13(1):38-49.
Study ID Numbers: C3951R
Last Updated: August 1, 2005
Record first received: August 1, 2005
ClinicalTrials.gov Identifier: NCT00126113
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-02
Source: ClinicalTrials.gov
Cache Date: August 3, 2005