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Sponsored by: |
Portland VA Medical Center |
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Information provided by: | Portland VA Medical Center |
ClinicalTrials.gov Identifier: | NCT00695162 |
Study Objectives:
Plan:
One hundred and twenty inpatients from the four medical/surgical nursing units at the Portland VA Medical Center, 60 with normal hearing and 60 with hearing impairment will be recruited to participate in the study. Following assessment to ascertain eligibility and obtaining informed consent, patients will be tested in a sound booth housed at the National Center for Rehabilitative Auditory Research (NCRAR). Designed so that each patient serves as his or her own control, we can accommodate considerable baseline variability between patients without adversely affecting required sample size. Patients' performance in speech intelligibility and recall tests will be measured using a constant level of speech, in controlled environments of no noise (baseline), white noise, hospital noise and hospital noise with speech, all delivered via headphones in pseudo-random order. Performance will be measured in each type of noise at decibel levels equivalent to those currently experienced on nursing units and at lower levels that prior studies have shown are more conducive to effective communication
By selecting measures that are particularly relevant to the safe care of hospitalized patients, and that have been studied extensively in healthy populations in highly controlled conditions, we expect to find compelling and unambiguous evidence that hospitalized patients correctly hear and recall very little of what is said to them during their hospitalizations. The majority of hospitalized patients stay on acute care nursing units during most or all of their hospitalizations, making this an appropriate population to study in the context of their responses to the noises typical in these environments. Perhaps most importantly, this study will heighten awareness of health-care personnel to the levels of impairment suffered by their patients - both in their ability to correctly interpret speech and to recall it - in the typical noisy environments of nursing units.
Condition | Intervention |
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Auditory Perception Memory Hearing Impairment |
Other: quiet Other: non-speech noise Other: speech noise |
Study Type: | Interventional |
Study Design: | Health Services Research, Non-Randomized, Open Label, Factorial Assignment |
Official Title: | Speech Intelligibility and Cognition: Are Inpatients Impaired by Noise? |
Estimated Enrollment: | 120 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
hearing impaired inpatients
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Other: quiet
no noise
Other: non-speech noise
noise without speech
Other: speech noise
noise with speech present
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2
Non-hearing-impaired inpatients
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Other: quiet
no noise
Other: non-speech noise
noise without speech
Other: speech noise
noise with speech present
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Ages Eligible for Study: | 18 Years to 88 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria for 60 participants with hearing impairment:
Exclusion criteria for the other 60 participants:
Contact: Diana S Pope, PhD, MS, RN | 503-220-8262 ext 54401 | diana.pope@va.gov |
United States, Oregon | |
Portland VA Medical Center | |
Portland, Oregon, United States, 97239 |
Principal Investigator: | Diana S Pope, PhD, MS, RN | Portland VA Medical Center |
Responsible Party: | Portland VA Medical Center ( Diana S. Pope, PhD, MS, RN, Principal investigator ) |
Study ID Numbers: | #11-3307 |
Study First Received: | June 9, 2008 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00695162 |
Health Authority: | United States: Federal Government |
noise speech intelligibility cognition |
Signs and Symptoms Sensation Disorders Hearing Disorders Deafness |
Otorhinolaryngologic Diseases Neurologic Manifestations Hearing Loss Ear Diseases |
Nervous System Diseases |