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CompletedNCT00695162Updated Feb 16, 2011

Speech Intelligibility and Cognition: Are Inpatients Impaired by Noise?

An interventional study of quiet and non-speech noise in Auditory Perception, Memory and Hearing Impairment, sponsored by Portland VA Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 88 Years. Per ClinicalTrials.gov, last updated 2011-02-16.

Sponsored by Portland VA Medical Center · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Non-randomized
Ages
18 Years to 88 Years
Sex
All
01

Study summary

Study Objectives:

    1. To examine the extent to which noise typical of nursing units reduces speech intelligibility in acutely ill hospitalized patients
    1. To examine the extent to which noise typical of nursing units impairs recall in acutely ill hospitalized patients
    1. 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.

02

Conditions studied

  • Auditory Perception
  • Memory
  • Hearing Impairment

Keywords

  • noise
  • speech intelligibility
  • cognition
03

In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's enrollment of 84 is above the median of 40 across 764 interventional studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Portland VA Medical Center is the lead sponsor of 18 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 88 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
84 participants (actual)

Study arms

  • Other
    1

    hearing impaired inpatients

    Other: quiet · Other: non-speech noise · Other: speech noise

  • Other
    2

    Non-hearing-impaired inpatients

    Other: quiet · Other: non-speech noise · Other: speech noise

Interventions

  • Otherquiet

    no noise

  • Othernon-speech noise

    noise without speech

  • Otherspeech noise

    noise with speech present

06

What researchers measure

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

    Time frame: 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

    Time frame: five minutes after presentation

07

Study locations

1 site
  • Portland VA Medical Center
    Portland, Oregon 97239, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00695162
Lead sponsor
Portland VA Medical Center
First posted
Jun 11, 2008
Start date
Jan 2010
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Feb 16, 2011

Study contacts

Diana S Pope, PhD, MS, RN
principal investigator · Portland VA Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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