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Speech Intelligibility and Cognition: Are Inpatients Impaired by Noise?

Primary Purpose

Auditory Perception, Memory, Hearing Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
quiet
non-speech noise
speech noise
Sponsored by
Portland VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Auditory Perception focused on measuring noise, speech intelligibility, cognition

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Portland VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

hearing impaired inpatients

Non-hearing-impaired inpatients

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 9, 2008
Last Updated
February 15, 2011
Sponsor
Portland VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00695162
Brief Title
Speech Intelligibility and Cognition: Are Inpatients Impaired by Noise?
Official Title
Speech Intelligibility and Cognition: Are Inpatients Impaired by Noise?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Portland VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auditory Perception, Memory, Hearing Impairment
Keywords
noise, speech intelligibility, cognition

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
hearing impaired inpatients
Arm Title
2
Arm Type
Other
Arm Description
Non-hearing-impaired inpatients
Intervention Type
Other
Intervention Name(s)
quiet
Intervention Description
no noise
Intervention Type
Other
Intervention Name(s)
non-speech noise
Intervention Description
noise without speech
Intervention Type
Other
Intervention Name(s)
speech noise
Intervention Description
noise with speech present
Primary Outcome Measure Information:
Title
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
Time Frame
immediately after presentation
Secondary Outcome Measure Information:
Title
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
Time Frame
five minutes after presentation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana S Pope, PhD, MS, RN
Organizational Affiliation
Portland VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Portland VA Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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Speech Intelligibility and Cognition: Are Inpatients Impaired by Noise?

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