Memory Clinical Trial
Official title:
Speech Intelligibility and Cognition: Are Inpatients Impaired by Noise?
Verified date | February 2011 |
Source | Portland VA Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
Study Objectives:
- 1. To examine the extent to which noise typical of nursing units reduces speech
intelligibility in acutely ill hospitalized patients
- 2. To examine the extent to which noise typical of nursing units impairs recall in
acutely ill hospitalized patients
- 3. To quantify severity of reduced performance associated with age, familiarity with
the healthcare setting, hearing and health status.
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 88 Years |
Eligibility |
Inclusion criteria: - Adult inpatients on medical/surgical nursing units at the Portland VA, greater than 18 years of age will be eligible to participate. Exclusion criteria for 60 participants with hearing impairment: - Cognitively or physically unable to participate (reported by patient or nurse); electronic chart notes indicate patient exhibits aggressive behavior, documented dementia, Alzheimer's disease, or severe psychosocial disorder, patient undergoing detoxification, individual is not legally capable of independently providing informed consent - Patients who are not native American English speakers. - Patients who exhibit Meniere's disease or retrocochlear disorder based on patient report or notes in patient's chart. - Patient exhibits active or recent history of middle ear disorder based on otoscopy, tympanometry, immittance or notes in patient chart; 5) patients unwilling to participate. Exclusion criteria for the other 60 participants: - Cognitively or physically unable to participate (reported by patient or nurse); electronic chart notes indicate patient exhibits aggressive behavior, documented dementia, Alzheimer's disease, or severe psychosocial disorder, patient undergoing detoxification, individual is not legally capable of independently providing informed consent - Patients who are not native American English speakers. - Patients who exhibit Meniere's disease or retrocochlear disorder based on patient report or notes in patient's chart. - Patient exhibits active or recent history of middle ear disorder based on otoscopy, tympanometry, immittance or notes in patient chart. - Patients with hearing loss that exceeds 25 dBHL in any frequency between .l5 and 3 kHz. - Patients unwilling to participate. |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | Portland VA Medical Center | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Portland VA Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the percent of correctly identified words at different signal-to-noise rations (levels +4, +8 and +12 db) above that of the two types of noise, relative to the percent identified in quiet | immediately after presentation | No | |
Secondary | Change in the percent of correctly recalled words at different signal-to-noise rations (levels +4, +8 and +12 db) above that of the two types of noise, relative to the percent recalled in quiet | five minutes after presentation | No |
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