Auditory PerceptionNCT00695162
Speech Intelligibility and Cognition: Are Inpatients Impaired by Noise?
A study testing quiet, non-speech noise and speech noise in people with Auditory Perception and Memory, run by Portland VA Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Auditory Perception, Memory, Hearing Impairment
- What is being tested?
- quiet, non-speech noise and speech noise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Auditory Perception, Memory, Hearing Impairment
- Being tested
- quiet, non-speech noise, speech noise
- Keywords
- noise, speech intelligibility, cognition
- Medical subject headings
- Hearing Loss, Speech Intelligibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quietOther
no noise
non-speech noiseOther
noise without speech
speech noiseOther
noise with speech present
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | hearing impaired inpatients Receives: Other: quiet; Other: non-speech noise; Other: speech noise |
| 2 | Other | Non-hearing-impaired inpatients Receives: Other: quiet; Other: non-speech noise; Other: speech noise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: five minutes after presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auditory PerceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portland VA Medical Center
- Sponsor type
- US federal agency
- Investigators
- Diana S Pope, PhD, MS, RN, Principal investigator, Portland VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695162
- Sponsor's protocol ID
- #11-3307
- Status last verified
- Feb 2011
- First submitted
- 9 Jun 2008
- Last updated
- 16 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech Intelligibility and Cognition: Are Inpatients Impaired by Noise?
- ClinicalTrials.gov ID
- NCT00695162
- Acronym / sponsor ID
- #11-3307
- Conditions
- Auditory Perception, Memory, Hearing Impairment
- Keywords
- noise, speech intelligibility, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Portland VA Medical CenterUS federal agency
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: quiet, Other: non-speech noise, Other: speech noisehearing impaired inpatients |
| 2 | Other | Other: quiet, Other: non-speech noise, Other: speech noiseNon-hearing-impaired inpatients |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult inpatients on medical/surgical nursing units at the Portland VA, greater than 18 years of age will be eligible 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; 5) patients unwilling to participate.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quietno noise | Other | 1, 2 |
| non-speech noisenoise without speech | Other | 1, 2 |
| speech noisenoise with speech present | Other | 1, 2 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana S Pope, PhD, MS, RN principal investigator
Portland VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quiet, non-speech noise and speech noise in people with Auditory Perception and Memory, run by Portland VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2011.