AgingNCT01253031
Working Memory Changes With Aging and Hearing Loss
An observational study of Aging and Hearing Loss, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Hearing loss is one of the most common health concerns affecting 1 in 3 Americans over 60 years of age rising to 1 in 2 for those over 85 years old. Contributions to hearing abilities provided by cognitive and memory processes are universally recognized as essential to adequate speech communication, but these… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Hearing Loss
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Dec 2012
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All populations meeting the inclusion criteria
Who may be able to join
- 18-30 years of age or 60-75 years of age
- Normal hearing or
- Mild to moderate hearing loss
- No major medical or memory problems
Who cannot join
- <24/30 on MMSE
- Conductive or mixed hearing loss.
- Hearing loss worse than 55dB in either ear.
- Taking medication known to alter concentration or alertness
- Inability to learn task after practice
- Major medical or psychological disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
About this study
Official title: Effects of Aging and Hearing Loss During Rapid Sound Processing
Hearing loss is one of the most common health concerns affecting 1 in 3 Americans over 60 years of age rising to 1 in 2 for those over 85 years old. Contributions to hearing abilities provided by cognitive and memory processes are universally recognized as essential to adequate speech communication, but these processes are not well understood. Cognitive limitations in the ability to rapidly process sequential sounds occur with all listeners but may have more impact on older Veterans with and without hearing impairment. The purpose of this study is to examine and more thoroughly characterize the change in auditory working memory with hearing loss and increasing age. Young and older listeners with and without hearing loss will listen and report on two target sounds embedded in a stream of rapidly occurring sound. The investigators expect that older listeners without hearing loss will have more difficulty than young listeners but that older listeners with hearing impairment will have the most difficulty with this task even when the sounds they are listening to are adjusted to compensate for their hearing loss.
Read the detailed description
The purpose of this pilot study is to understand how memory changes with aging and if failures of working memory during rapid sound processing may account for some of the speech perception difficulties reported by older Veteran listeners especially those with hearing loss. A period of processing interference (and limitation) has been identified during rapid auditory or visual processing. Specifically, when subjects are asked to report on two targeted events embedded in a rapid stream of distractor events, the ability to report on the second target is diminished when it occurs at an interval of approximately 200-400ms following the first target. This has been identified as a failure of working memory consolidation and is robust during both visual and auditory processing. Much is known about how the failure of working memory affects young normal hearing listeners but little is known of its effect on older listeners or listeners with hearing loss. A lengthened period of processing interference is very likely to be present among older listeners. This is important because speech is rapid and older listeners often report difficulty in auditory environments in which multiple speakers are present. Further, older listeners, who are more likely to have hearing loss, continue to report more problems hearing in noisy environments even with their hearing aids optimally functional. The presence of a prolonged period of processing interference in the auditory system could account for some of these complaints and, if more completely understood, could be remediated.
Up to 75 subjects, ages 18-30 and 60-75 years will be invited to participate. Subjects will undergo a complete audiological evaluation done to assign them into one of three arms/groups of up to15 subjects each. Arms will be composed of young subjects with normal hearing (YNH), older subjects with normal hearing (ONH) and older subjects with mild hearing impairment (OHI). Each subject will be asked to listen to between 18 and 26 non-overlapping tones each 30ms in duration followed by a 70ms silent interval. Target tones and tone complexes (T1 and T2) will be embedded in this stream. Sequences could contain (in equal probability) a) no target, b) T1 only, c) T2 only or d) both targets. At the end of each stream, the subject will be required to make an untimed judgment about whether the stream contained T1 (yes/no) and T2 (yes/no). This project is self-paced. The hypothesized findings are that young listeners without hearing impairment will have more difficulty reporting on T2 when it follows T1 by approximately 200-400ms than at any other interval. However, older listeners without hearing impairment will demonstrate a more prolonged period of interference (>400ms) with slightly poorer performance overall while older listeners with hearing impairment will have an even longer lasting period of processing interference and overall larger deficit (poorer performance) suggesting that increasing age and hearing impairment combine to reveal significant processing deficits for this group. These results would provide a much needed explanation of the ways in which rapid processing (precisely what speech is) is degraded by hearing impairment, aging, and a combination of the two.
- Conditions
- Aging, Hearing Loss
- Keywords
- hearing loss, aging, short term memory, attentional blink
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | young normal hearing | |
| Group 2 | older normal hearing | |
| Group 3 | older hearing impaired |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time between targets (lag time)
The subjects will be trained to hear each target sound in a sequence of sounds. The target sounds will vary in terms of how closely they occur to each other. Closer (in time, also called lag time) targets will be harder to hear than far apart (in time) targets.
Measured: At time of consent up to 2 weeks from consent
Secondary outcomes (1)
Percent correct
Measured: At time of consent up to 2 weeks from consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startMar 2011
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Marilyn L Dille, PhD, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253031
- Sponsor's protocol ID
- C6928-P
- Status last verified
- Dec 2015
- First submitted
- 1 Dec 2010
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aging and Hearing Loss During Rapid Sound Processing
- ClinicalTrials.gov ID
- NCT01253031
- Acronym / sponsor ID
- C6928-P
- Conditions
- Aging, Hearing Loss
- Keywords
- hearing loss, aging, short term memory, attentional blink
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Mar 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 Dec 2010 (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.
Hearing loss is one of the most common health concerns affecting 1 in 3 Americans over 60 years of age rising to 1 in 2 for those over 85 years old. Contributions to hearing abilities provided by cognitive and memory processes are universally recognized as essential to adequate speech communication, but these processes are not well understood. Cognitive limitations in the ability to rapidly process sequential sounds occur with all listeners but may have more impact on older Veterans with and without hearing impairment. The purpose of this study is to examine and more thoroughly characterize the change in auditory working memory with hearing loss and increasing age. Young and older listeners with and without hearing loss will listen and report on two target sounds embedded in a stream of rapidly occurring sound. The investigators expect that older listeners without hearing loss will have more difficulty than young listeners but that older listeners with hearing impairment will have the most difficulty with this task even when the sounds they are listening to are adjusted to compensate for their hearing loss.
Detailed description
The purpose of this pilot study is to understand how memory changes with aging and if failures of working memory during rapid sound processing may account for some of the speech perception difficulties reported by older Veteran listeners especially those with hearing loss. A period of processing interference (and limitation) has been identified during rapid auditory or visual processing. Specifically, when subjects are asked to report on two targeted events embedded in a rapid stream of distractor events, the ability to report on the second target is diminished when it occurs at an interval of approximately 200-400ms following the first target. This has been identified as a failure of working memory consolidation and is robust during both visual and auditory processing. Much is known about how the failure of working memory affects young normal hearing listeners but little is known of its effect on older listeners or listeners with hearing loss. A lengthened period of processing interference is very likely to be present among older listeners. This is important because speech is rapid and older listeners often report difficulty in auditory environments in which multiple speakers are present. Further, older listeners, who are more likely to have hearing loss, continue to report more problems hearing in noisy environments even with their hearing aids optimally functional. The presence of a prolonged period of processing interference in the auditory system could account for some of these complaints and, if more completely understood, could be remediated.
Up to 75 subjects, ages 18-30 and 60-75 years will be invited to participate. Subjects will undergo a complete audiological evaluation done to assign them into one of three arms/groups of up to15 subjects each. Arms will be composed of young subjects with normal hearing (YNH), older subjects with normal hearing (ONH) and older subjects with mild hearing impairment (OHI). Each subject will be asked to listen to between 18 and 26 non-overlapping tones each 30ms in duration followed by a 70ms silent interval. Target tones and tone complexes (T1 and T2) will be embedded in this stream. Sequences could contain (in equal probability) a) no target, b) T1 only, c) T2 only or d) both targets. At the end of each stream, the subject will be required to make an untimed judgment about whether the stream contained T1 (yes/no) and T2 (yes/no). This project is self-paced. The hypothesized findings are that young listeners without hearing impairment will have more difficulty reporting on T2 when it follows T1 by approximately 200-400ms than at any other interval. However, older listeners without hearing impairment will demonstrate a more prolonged period of interference (>400ms) with slightly poorer performance overall while older listeners with hearing impairment will have an even longer lasting period of processing interference and overall larger deficit (poorer performance) suggesting that increasing age and hearing impairment combine to reveal significant processing deficits for this group. These results would provide a much needed explanation of the ways in which rapid processing (precisely what speech is) is degraded by hearing impairment, aging, and a combination of the two.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –young normal hearing |
| Group 2 | – | –older normal hearing |
| Group 3 | – | –older hearing impaired |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All populations meeting the inclusion criteria
Key inclusion criteria (4 listed)
- 18-30 years of age or 60-75 years of age
- Normal hearing or
- Mild to moderate hearing loss
- No major medical or memory problems
Key exclusion criteria (6 listed)
- <24/30 on MMSE
- Conductive or mixed hearing loss.
- Hearing loss worse than 55dB in either ear.
- Taking medication known to alter concentration or alertness
- Inability to learn task after practice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time between targets (lag time)
Time frame: At time of consent up to 2 weeks from consent
The subjects will be trained to hear each target sound in a sequence of sounds. The target sounds will vary in terms of how closely they occur to each other. Closer (in time, also called lag time) targets will be harder to hear than far apart (in time) targets.
1 secondary outcome
Percent correct
Time frame: At time of consent up to 2 weeks from consent
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 23 Dec 2015.
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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.
Marilyn L Dille, PhD principal investigator
VA Portland Health Care System, Portland, OR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Hearing Loss, run by VA Office of Research and Development 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 4 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 23 Dec 2015. 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?
Time between targets (lag time) (time frame: At time of consent up to 2 weeks from consent). 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 23 Dec 2015.