Hearing LossNCT04281225
Mindfulness Intervention and Symptom Variability in Hearing
A study testing Attention to Variability (ATV) in people with Hearing Loss, run by Harvard University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the efficacy of mindfulness and placebo treatments on hearing improvement. More specifically, the researchers will be investigating whether the following variables impact the effectiveness of placebo treatment such as: mindfulness, and attention to variability. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Attention to Variability (ATV)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 1 Mar 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 80 years of age
- Eyesight with corrective lenses sufficient enough to read and respond to emails
- Owns or has access to and is familiar with using a smartphone and/or desk top/laptop with a cellular data plan and email host
- Able to receive and respond to text messages and emails
- Able to and access to watch, listen to and operate on a phone or computer a video or recording
- English speaking and reading at 8th grade level
- Self-Perceived mild to moderate hearing problem with onset after age 18 (adult onset)
Who cannot join
- Under age 18 or over age 80
- Unable to read and respond to texts or emails
- No Smartphone or desktop/laptop access
- Hearing loss onset prior to age 18
- Co-morbid conditions such as cancer, diabetes, cardiovascular disease diagnosed and under treatment in the past 6 months
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the efficacy of mindfulness and placebo treatments on hearing improvement. More specifically, the researchers will be investigating whether the following variables impact the effectiveness of placebo treatment such as: mindfulness, and attention to variability. Extant research has found the effectiveness of psychological treatment in multiple domains, and the researchers look to further investigate this success in the domain of hearing symptom sensations.
Read the detailed description
The placebo effect, described as "psychological or physiological responses attributed to expectations of an inert substance or procedure, has been demonstrated to have powerful effects in multiple instances (Colloca \& Benedetti, 2005). Although research on the placebo effect is prolific, the mechanisms involved can vary based on the context and have been difficult to research with consistent approaches and results (Brown et al., 2013; Holmes et al., 2018). Some researchers have found that the mere perception of a treatment as "new" is enough to elicit a placebo effect, while others have found that the key mechanism may be attention to symptoms - nevertheless, "little evidence exists on the precise mechanisms through which psychological treatments actually work" (Brown et al., 2013; Holmes et al., 2018).
Earlier work suggests the potential for psychological treatments for hearing loss or other forms of hearing disability, including coping techniques (Scott et al, 2009). This study aims to extend the mind-body unity theory as suggested by Dawes et al. (2013) who found in two successive studies that there is a reliable placebo effect in hearing-aid trials. While the objective of these studies was to encourage double-blind methodology (to optimize results), these results suggest that such effects can optimize outcomes and as the audiology field does not typically consider placebo effects. it suggests that hearing improvements can be impacted by (positive) expectations in a "general" sense (not a specific type of hearing aid but simply a "new technology" hearing aid). While this will be of great use clinically in double blind trials, it suggests that the use of a psychological construct, specifically the Langerian attention to variability construct, can function to encourage a placebo effect or a clinical response by encouraging a sense of personal control over the symptoms of the hearing loss. In this study, researchers will look to further investigate one potential mechanism important to the placebo effect - attention to variability.
- Conditions
- Hearing Loss
- Being tested
- Attention to Variability (ATV), Placebo
- Keywords
- attention to variability, placebo, hearing
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention to Variability (ATV)Behavioural
In Attention to Variability we ask the participant to attend to the natural fluctuations in mood and behavior that occur throughout the day, and to notice changes they experience with their hearing loss symptoms; noticing if it is better or worse and to ask why it may be.
PlaceboOther
Participants are told that the device they will be testing will improve their hearing, when in fact the device is not a hearing aid but just a metallic earring.
| Study group | Role | What they receive |
|---|---|---|
| Placebo only condition | Placebo comparator | Participants in this condition will be told at the time of the initial assessments (T1) that the device they will be testing will improve their hearing. All participants will be instructed to put on the hearing device and listen to an audio twice per day for 6 days. After listening to the 2nd audio of the day, they will be asked if they perceive their hearing to be changed by the device in addition to qualitative descriptions of the audio. This group will allow researchers to investigate the main effect of the placebo hearing aid - without calling participant's attention to variability in their symptoms. Receives: Other: Placebo |
| Placebo and ATV condition | Experimental | Participants in this condition at the time of the initial assessments (T1) will be told that the device they will be testing will improve their hearing. They will then be told that in-order to receive the maximum benefit from the hearing device, they should focus on instances in which they can hear better and worse. All participants will be instructed to put on the hearing device and listen to an audio twice per day for 6 days. After listening to the 2nd audio of the day, they will asked 1) if they perceive their hearing to be changed by the device; 2) to note any changes in what they heard in the audio focusing on the story in the ballad; and 3) whether their hearing is possibly impacted by activities and behavior and what they were doing.This condition will enable researchers to test the effects of the interaction between attention to variability and the placebo effect. Receives: Behavioral: Attention to Variability (ATV); Other: Placebo |
| ATV only condition | Experimental | Participants in this condition will be told that the device they will be testing is merely a prototype that they are testing for design purposes. However, these participants will also be told that their input while wearing the device will help the team in developing the final device and allow the team to focus on how to best improve hearing. All participants will be instructed to put on the hearing device and listen to an audio twice per day for 6 days. After listening to the 2nd audio of the day, they will be asked 1) to note any changes in what they heard in the audio focusing on the story in the ballad and 2) whether their hearing might possibly be impacted by activities and behavior. They will also be asked 3) about their general health and wellness, as compared to the last time they were contacted by email. This condition will enable researchers to test the main effect of attention to variability, without an explicit placebo effect. Receives: Behavioral: Attention to Variability (ATV) |
| Control condition- no ATV or Placebo effect. | No intervention | Participants in this condition will be told that the device they will be testing is merely a prototype that they are testing for ergonomic purposes. They will listen to the audio and record volume levels at the start and at the end of the audio and provide feedback on the design. They will be told that each day they will listen to a brief audio (ballad of under 3 minutes) and will be asked a few similar questions twice daily for 6 days. After the 2nd audio of the day, they will be asked for feedback on the hearing device design. They will also be asked about their general health and wellness, as compared to the last time they were contacted.This group will allow researchers to test for the effects of having any device at all. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing Change - subjective preferred volume
Participants will be told to wear the hearing device and listen to a brief audio (ballad of under 3 minutes) twice a day daily for 6 days.The survey will ask them to listen to the audio and record the volume level that they used at the beginning and at the end, and then answer a few questions after. The change in participants subjective preferred volume over the course of the week , compared to T1 at the beginning of the week, will represent hearing change.
Measured: 5 minutes daily for 6 days
Secondary outcomes (4)
Langer Mindfulness Scale,14-Item scale
3 subscales, each ranging from 1-7, with 1 being 'Strongly Disagree' and 7 being 'Strongly Agree'. Subscales are 'Flexibility'; 'Novelty Seeking'; and 'Novelty Producing'.Ratings on these items are then added together to create a score for each subscale and an overall mindfulness score. Higher scores indicate greater mindfulness, and can range from 14 to 98.
Measured: 5 minutes
Perceived Stress Scale (PSS)
This 10 item scale asks questions about one's feelings and thoughts during the past month. In each question, individuals are asked how often they felt or thought a certain way on a scale from 0 (Never) to 4 (Very Often). Scores can range from 0 to 40, with a greater values is indicating greater perceived stress.
Scoring: Each item is rated on a 5-point scale ranging from (0) never to (4) almost always
Measured: 5 minutes
Hearing Handicap Inventory for Elderly- Screening (HHIE-S)
For participants over the age of 65. The Hearing Handicap Inventory for the Elderly Screening Version (HHIE-S) is a 10-item questionnaire that assesses how an individual perceives the social and emotional effects of hearing loss. The higher the HHIE-S score, the greater the handicapping effect of a hearing impairment. Possible scores range from 0 (no handicap) to 40 (maximum handicap).
Measured: 5 minutes
Hearing Handicap Inventory for Adults- Screening (HHIA-S)
Similar to the HHIE-S above but for adult participants under the age of 65. The higher the HHIA- S score, the greater the handicapping effect of a hearing impairment. Possible scores range from 0 (no handicap) to 40 (maximum handicap).
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start1 Nov 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Why it stopped: With COVID, we are not able to conduct any in-person research at this time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Langer, Harvard University
- Investigators
- Ellen Langer, Ph.D., Principal investigator, Harvard U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281225
- Sponsor's protocol ID
- IRB19-0222
- Status last verified
- Feb 2022
- First submitted
- 20 Feb 2020
- Last updated
- 17 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bertisch SM, Legedza AR, Phillips RS, Davis RB, Stason WB, Goldman RH, Kaptchuk TJ. The impact of psychological factors on placebo responses in a randomized controlled trial comparing sham device to dummy pill. J Eval Clin Pract. 2009 Feb;15(1):14-9. doi: 10.1111/j.1365-2753.2008.00942.x.
PubMed 19239577Dawes P, Hopkins R, Munro KJ. Placebo effects in hearing-aid trials are reliable. Int J Audiol. 2013 Jul;52(7):472-7. doi: 10.3109/14992027.2013.783718. Epub 2013 Apr 18.
PubMed 23594421Labus J, Breil J, Stutzer H, Michel O. Meta-analysis for the effect of medical therapy vs. placebo on recovery of idiopathic sudden hearing loss. Laryngoscope. 2010 Sep;120(9):1863-71. doi: 10.1002/lary.21011.
PubMed 20803741Brown, J. A., Fowler, S. L., Rasinski, H. M., Rose, J. P., & Geers, A. L. (2013). Choice as a moderator of placebo expectation effects: Additional support from two experiments. Basic and Applied Social Psychology, 35(5), 436-444.
Holmes EA, Ghaderi A, Harmer CJ, Ramchandani PG, Cuijpers P, Morrison AP, Roiser JP, Bockting CLH, O'Connor RC, Shafran R, Moulds ML, Craske MG. The Lancet Psychiatry Commission on psychological treatments research in tomorrow's science. Lancet Psychiatry. 2018 Mar;5(3):237-286. doi: 10.1016/S2215-0366(17)30513-8. No abstract available.
PubMed 29482764
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Intervention and Symptom Variability in Hearing
- ClinicalTrials.gov ID
- NCT04281225
- Acronym / sponsor ID
- IRB19-0222
- Conditions
- Hearing Loss
- Keywords
- attention to variability, placebo, hearing
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: With COVID, we are not able to conduct any in-person research at this time
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Harvard UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 24 Feb 2020 (actual)
- 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.
The purpose of this study is to investigate the efficacy of mindfulness and placebo treatments on hearing improvement. More specifically, the researchers will be investigating whether the following variables impact the effectiveness of placebo treatment such as: mindfulness, and attention to variability. Extant research has found the effectiveness of psychological treatment in multiple domains, and the researchers look to further investigate this success in the domain of hearing symptom sensations.
Detailed description
The placebo effect, described as "psychological or physiological responses attributed to expectations of an inert substance or procedure, has been demonstrated to have powerful effects in multiple instances (Colloca \& Benedetti, 2005). Although research on the placebo effect is prolific, the mechanisms involved can vary based on the context and have been difficult to research with consistent approaches and results (Brown et al., 2013; Holmes et al., 2018). Some researchers have found that the mere perception of a treatment as "new" is enough to elicit a placebo effect, while others have found that the key mechanism may be attention to symptoms - nevertheless, "little evidence exists on the precise mechanisms through which psychological treatments actually work" (Brown et al., 2013; Holmes et al., 2018).
Earlier work suggests the potential for psychological treatments for hearing loss or other forms of hearing disability, including coping techniques (Scott et al, 2009). This study aims to extend the mind-body unity theory as suggested by Dawes et al. (2013) who found in two successive studies that there is a reliable placebo effect in hearing-aid trials. While the objective of these studies was to encourage double-blind methodology (to optimize results), these results suggest that such effects can optimize outcomes and as the audiology field does not typically consider placebo effects. it suggests that hearing improvements can be impacted by (positive) expectations in a "general" sense (not a specific type of hearing aid but simply a "new technology" hearing aid). While this will be of great use clinically in double blind trials, it suggests that the use of a psychological construct, specifically the Langerian attention to variability construct, can function to encourage a placebo effect or a clinical response by encouraging a sense of personal control over the symptoms of the hearing loss. In this study, researchers will look to further investigate one potential mechanism important to the placebo effect - attention to variability.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo only condition | Placebo comparator | Other: PlaceboParticipants in this condition will be told at the time of the initial assessments (T1) that the device they will be testing will improve their hearing. All participants will be instructed to put on the hearing device and listen to an audio twice per day for 6 days. After listening to the 2nd audio of the day, they will be asked if they perceive their hearing to be changed by the device in addition to qualitative descriptions of the audio. This group will allow researchers to investigate the main effect of the placebo hearing aid - without calling participant's attention to variability in their symptoms. |
| Placebo and ATV condition | Experimental | Behavioral: Attention to Variability (ATV), Other: PlaceboParticipants in this condition at the time of the initial assessments (T1) will be told that the device they will be testing will improve their hearing. They will then be told that in-order to receive the maximum benefit from the hearing device, they should focus on instances in which they can hear better and worse. All participants will be instructed to put on the hearing device and listen to an audio twice per day for 6 days. After listening to the 2nd audio of the day, they will asked 1) if they perceive their hearing to be changed by the device; 2) to note any changes in what they heard in the audio focusing on the story in the ballad; and 3) whether their hearing is possibly impacted by activities and behavior and what they were doing.This condition will enable researchers to test the effects of the interaction between attention to variability and the placebo effect. |
| ATV only condition | Experimental | Behavioral: Attention to Variability (ATV)Participants in this condition will be told that the device they will be testing is merely a prototype that they are testing for design purposes. However, these participants will also be told that their input while wearing the device will help the team in developing the final device and allow the team to focus on how to best improve hearing. All participants will be instructed to put on the hearing device and listen to an audio twice per day for 6 days. After listening to the 2nd audio of the day, they will be asked 1) to note any changes in what they heard in the audio focusing on the story in the ballad and 2) whether their hearing might possibly be impacted by activities and behavior. They will also be asked 3) about their general health and wellness, as compared to the last time they were contacted by email. This condition will enable researchers to test the main effect of attention to variability, without an explicit placebo effect. |
| Control condition- no ATV or Placebo effect. | No intervention | –Participants in this condition will be told that the device they will be testing is merely a prototype that they are testing for ergonomic purposes. They will listen to the audio and record volume levels at the start and at the end of the audio and provide feedback on the design. They will be told that each day they will listen to a brief audio (ballad of under 3 minutes) and will be asked a few similar questions twice daily for 6 days. After the 2nd audio of the day, they will be asked for feedback on the hearing device design. They will also be asked about their general health and wellness, as compared to the last time they were contacted.This group will allow researchers to test for the effects of having any device at all. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Between 18 and 80 years of age
- Eyesight with corrective lenses sufficient enough to read and respond to emails
- Owns or has access to and is familiar with using a smartphone and/or desk top/laptop with a cellular data plan and email host
- Able to receive and respond to text messages and emails
- Able to and access to watch, listen to and operate on a phone or computer a video or recording
Key exclusion criteria (6 listed)
- Under age 18 or over age 80
- Unable to read and respond to texts or emails
- No Smartphone or desktop/laptop access
- Hearing loss onset prior to age 18
- Co-morbid conditions such as cancer, diabetes, cardiovascular disease diagnosed and under treatment in the past 6 months
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 |
|---|---|---|
| Attention to Variability (ATV)In Attention to Variability we ask the participant to attend to the natural fluctuations in mood and behavior that occur throughout the day, and to notice changes they experience with their hearing loss symptoms; noticing if it is better or worse and to ask why it may be. | Behavioural | ATV only condition, Placebo and ATV condition |
| PlaceboParticipants are told that the device they will be testing will improve their hearing, when in fact the device is not a hearing aid but just a metallic earring. | Other | Placebo and ATV condition, Placebo only condition |
Primary outcome
Hearing Change - subjective preferred volume
Time frame: 5 minutes daily for 6 days
Participants will be told to wear the hearing device and listen to a brief audio (ballad of under 3 minutes) twice a day daily for 6 days.The survey will ask them to listen to the audio and record the volume level that they used at the beginning and at the end, and then answer a few questions after. The change in participants subjective preferred volume over the course of the week , compared to T1 at the beginning of the week, will represent hearing change.
4 secondary outcomes
Langer Mindfulness Scale,14-Item scale
Time frame: 5 minutes
Perceived Stress Scale (PSS)
Time frame: 5 minutes
Hearing Handicap Inventory for Elderly- Screening (HHIE-S)
Time frame: 5 minutes
Hearing Handicap Inventory for Adults- Screening (HHIA-S)
Time frame: 5 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Background: PubMed 19239577Bertisch SM, Legedza AR, Phillips RS, Davis RB, Stason WB, Goldman RH, Kaptchuk TJ. The impact of psychological factors on placebo responses in a randomized controlled trial comparing sham device to dummy pill. J Eval Clin Pract. 2009 Feb;15(1):14-9. doi: 10.1111/j.1365-2753.2008.00942.x.
- Background: PubMed 23594421Dawes P, Hopkins R, Munro KJ. Placebo effects in hearing-aid trials are reliable. Int J Audiol. 2013 Jul;52(7):472-7. doi: 10.3109/14992027.2013.783718. Epub 2013 Apr 18.
- Background: PubMed 20803741Labus J, Breil J, Stutzer H, Michel O. Meta-analysis for the effect of medical therapy vs. placebo on recovery of idiopathic sudden hearing loss. Laryngoscope. 2010 Sep;120(9):1863-71. doi: 10.1002/lary.21011.
- BackgroundBrown, J. A., Fowler, S. L., Rasinski, H. M., Rose, J. P., & Geers, A. L. (2013). Choice as a moderator of placebo expectation effects: Additional support from two experiments. Basic and Applied Social Psychology, 35(5), 436-444.
- Background: PubMed 29482764Holmes EA, Ghaderi A, Harmer CJ, Ramchandani PG, Cuijpers P, Morrison AP, Roiser JP, Bockting CLH, O'Connor RC, Shafran R, Moulds ML, Craske MG. The Lancet Psychiatry Commission on psychological treatments research in tomorrow's science. Lancet Psychiatry. 2018 Mar;5(3):237-286. doi: 10.1016/S2215-0366(17)30513-8. No abstract available.
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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.
Ellen Langer, Ph.D. principal investigator
Harvard U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attention to Variability (ATV) in people with Hearing Loss, run by Harvard University 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 7 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: withdrawn, as of the sponsor's last update on 17 Feb 2022. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Hearing Change - subjective preferred volume (time frame: 5 minutes daily for 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04281225, which also lists 5 linked publications.
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 17 Feb 2022.