Speech Intelligibility and Cognition: Are Inpatients Impaired by Noise?

This study has been completed.
Sponsor:
Information provided by:
Portland VA Medical Center
ClinicalTrials.gov Identifier:
NCT00695162
First received: June 9, 2008
Last updated: February 15, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Auditory Perception
Memory
Hearing Impairment
Other: quiet
Other: non-speech noise
Other: speech noise

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Speech Intelligibility and Cognition: Are Inpatients Impaired by Noise?

Resource links provided by NLM:


Further study details as provided by Portland VA Medical Center:

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 [ Time Frame: immediately after presentation ] [ Designated as safety issue: No ]

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 [ Time Frame: five minutes after presentation ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
hearing impaired inpatients
Other: quiet
no noise
Other: non-speech noise
noise without speech
Other: speech noise
noise with speech present
2
Non-hearing-impaired inpatients
Other: quiet
no noise
Other: non-speech noise
noise without speech
Other: speech noise
noise with speech present

  Eligibility

Ages Eligible for Study:   18 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695162

Locations
United States, Oregon
Portland VA Medical Center
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Portland VA Medical Center
Investigators
Principal Investigator: Diana S Pope, PhD, MS, RN Portland VA Medical Center
  More Information

No publications provided

Responsible Party: Diana S. Pope, PhD, MS, RN, Principal investigator, Portland VA Medical Center
ClinicalTrials.gov Identifier: NCT00695162     History of Changes
Other Study ID Numbers: #11-3307
Study First Received: June 9, 2008
Last Updated: February 15, 2011
Health Authority: United States: Federal Government

Keywords provided by Portland VA Medical Center:
noise
speech intelligibility
cognition

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014