Speech Intelligibility and Cognition: Are Inpatients Impaired by Noise?

Memory Clinical Trial

Official title:

Speech Intelligibility and Cognition: Are Inpatients Impaired by Noise?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00695162
• Other study ID #: #11-3307
• Status: Completed
• Phase: N/A
• First received: June 9, 2008
• Last updated: February 15, 2011
• Start date: January 2010
• Est. completion date: December 2010

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Auditory Perception
• Deafness
• Hearing Impairment
• Hearing Loss
• Memory

Intervention

Other:
• quiet
no noise
• non-speech noise
noise without speech
• speech noise
noise with speech present

Locations

Country	Name	City	State
United States	Portland VA Medical Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Portland VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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