Speech Intelligibility and Cognition: Are Inpatients Impaired by Noise?
1 other identifier
interventional
84
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2008
CompletedFirst Posted
Study publicly available on registry
June 11, 2008
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFebruary 16, 2011
February 1, 2011
11 months
June 9, 2008
February 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
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
Study Arms (2)
1
OTHERhearing impaired inpatients
2
OTHERNon-hearing-impaired inpatients
Interventions
Eligibility Criteria
You may qualify if:
- Adult inpatients on medical/surgical nursing units at the Portland VA, greater than 18 years of age will be eligible to participate.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Portland VA Medical Center
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diana S Pope, PhD, MS, RN
Portland VA Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
June 9, 2008
First Posted
June 11, 2008
Study Start
January 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
February 16, 2011
Record last verified: 2011-02