Hearing LossInHEARNCT05154539
Innovation of Hearing Rehabilitation and Effects of Reform
A study testing Remote digital assessment and Conventional physical assessment in people with Hearing Loss, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
The Danish health care system has been criticized for its structural inefficiency and latency to initiate proper hearing rehabilitation amongst hearing-impaired individuals. Waiting lists are extensive, and audiometries are repeated before hearing aid treatment is initiated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Remote digital assessment and Conventional physical assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 751 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Mar 2021to 1 Jun 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjective hearing difficulty
- Must be able to understand and read Danish
Who cannot join
- Recent ENT specialist assessment
- Prior HA usage
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Otorhinolaryngology and Audiology, Aalborg University Hospital
Aalborg, 9000
About this study
The Danish health care system has been criticized for its structural inefficiency and latency to initiate proper hearing rehabilitation amongst hearing-impaired individuals. Waiting lists are extensive, and audiometries are repeated before hearing aid treatment is initiated. Demographic changes forecast increasing numbers of +65-year-olds and consequently increased demand for hearing rehabilitation. To remedy this situation, the Danish Ministry of Health has proposed a new national initiative to implement innovative digital approaches to improve hearing rehabilitation, including a new, digital remote assessment routine.
The aim of this study is to investigate:
Read more
Primarily:
- Patient safety of remote vs. conventional assessment
- Patient-reported satisfaction and treatment effect of remote vs. conventional assessment Secondarily:
- Inter-subspecialty and inter-personal assessment differences between four ENT specialists using a remote assessment routine
- Translation and validation of the Danish adapted version of the Consumer Ear Disease Risk Assessment (CEDRA) questionnaire.
The main study is a randomized clinical trial with three arms and 1:1:1 assignment comprising 751 potential first-time adult hearing aid users.
Since March 2021, 751 patients have been randomized and assigned to 20 different clinics. The remote assessment routine works well for both patients, assessors, and clinics. Inclusion is expected to end in December 2021 and overall study completion is anticipated in april 2022.
Deficient diagnosis of complicating conditions in first time hearing aid users is the main concern in remote assessment. If the study shows the practice to be safe, it could form the foundation of a future nationwide implementation of remote care in Danish hearing rehabilitation.
Read the detailed description
InHEAR is a prospective randomized controlled trial aimed to investigate a new, Danish digital remote assessment routine applied in 751 hearing-impaired adults. The existing, traditional Danish referral model requires a physical consultation with an ear-nose- and throat (ENT) specialist prior to treatment initiation. The digital referral reform replaces the traditional physical ENT specialist assessment with a standardized examination package performed by educated and experienced audiology assistants, allowing physicians to assess and refer hearing-impaired adults to the relevant treatment regime remotely and asynchronously without meeting the patients physically.
After inclusion, the participants will be randomized equally into three groups:
Test group 1 (TG1) will be testing the digital assessment routine in private hearing clinics.
Test group 2 (TG2) will be testing the digital assessment routine in public hearing clinics.
Control group 3 (CG3) will be assessed in accordance with current Danish practice.
The examination package performed on test group participants comprises of:
- A standardized, focused medical hearing history record (questionnaire)
- A standard audiometry test, including air conduction, bone conduction, speech discrimination test and acoustic reflex test
- Tympanometry
- Still images of the eardrums performed by video-otoscopy
Four ENT-specialists, two audiologists and to private ENT specialist, will independently and remotely assess the standardized test group examination packages and refer the test group participants to relevant treatment. Participants in the control group are assessed by a private ENT specialist at a physical consultation and referred to relevant treatment in accordance with current Danish practice. Participants with simple hearing loss will be offered hearing rehabilitation with hearing aids. Participants with complicated hearing loss or complicated ear related diseases will be offered a physical ENT specialist assessment at the Department of Audiology at Aalborg University Hospital prior to treatment initiation.
Patient-reported data concerning treatment satisfaction-, quality- and effect will be registered throughout the study period.
Two-three months after treatment initiation, all participants are evaluated by an ENT specialist in Audiology or Otology at a "golden standard" physical consultation at the Department of Audiology at Aalborg University Hospital. Assessment and referral accuracy, patient-reported treatment quality and satisfaction between the test groups and the control group participants will be compared.
- Conditions
- Hearing Loss
- Being tested
- Remote digital assessment, Conventional physical assessment
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote digital assessmentDiagnostic test
Remote digital assessment of test group participants
Conventional physical assessmentDiagnostic test
Conventional physical assessment of control group participants
| Study group | Role | What they receive |
|---|---|---|
| Test Group 1 (TG1) | Experimental | TG1 participants are testing the new digital assessment routine in a private setting.
Audiology assistants in private hearing clinics located in the Region of Northern Jutland in Denmark are performing the standardized examination packages. The private hearing clinics also conduct hearing aid treatment for TG1 participants with simple hearing loss.
TG21 participants with complicated hearing loss or ear-related diseases are referred to the Department of Audiology at Aalborg University Hospital for further examination prior to treatment initiation. Receives: Diagnostic Test: Remote digital assessment |
| Test Group 2 (TG2) | Experimental | TG2 participants are testing the new digital assessment routine in a public setting.
Audiology assistants in public hearing clinics located in the Region of Northern Jutland in Denmark are performing the standardized examination packages. The public hearing clinics also conduct hearing aid treatment for TG2 participants with simple hearing loss.
TG2 participants with complicated hearing loss or ear-related diseases are referred to the Department of Audiology at Aalborg University Hospital for further examination prior to treatment initiation. Receives: Diagnostic Test: Remote digital assessment |
| Control Group 3 (CG3) | Active comparator | CG3 participants will be assessed conventionally by a private practicing ENT specialist in the Region of Northern Jutland in Denmark at physical consultation in accordance with current Danish practice. CG3 participants with simple hearing loss can choose whether hearing aid treatment should be conducted in either a private or a public hearing clinic.
CG3 participants with complicated hearing loss or ear-related diseases are referred to the Department of Audiology at Aalborg University Hospital for further examination prior to treatment initiation. Receives: Diagnostic Test: Conventional physical assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of complicating hearing and/or ear-related conditions in hearing impaired adults
ENT specialist assessments were performed remotely in test group participants and physically in control group participants at baseline. Based on this assessment, participants were divided into three categories of simple hearing loss, severe/complicated hearing loss, and no hearing loss respectively. Hearing aid treatment was administered when indicated.
The primary focus was to correctly identify participants with severe/complicated hearing loss and/or complicating ear-related conditions in both test and control groups.
Measured: Baseline
Remote ENT specialist assessment: Diagnostic accuracy of severe/complicated hearing loss and/or complicating ear-related conditions in hearing impaired adults.
A physical, "golden standard" ENT assessment was performed in all test group participants after 3 months. Based on this assessment, participants were again divided into categories of simple hearing loss, severe/complicated hearing loss, and no hearing loss respectively. The "golden standard" ENT assessment at Month 3 was compared to the remote ENT assessment at baseline and diagnostic differences were registered.
Outcome measures: Sensitivity and specificity of the remote ENT specialist assessment routine in identifying severe/complicated hearing loss and/or complicating ear-related conditions in hearing impaired adults.
Measured: Month 3
Conventional, physical ENT specialist assessment: Diagnostic accuracy of severe/complicated hearing loss and/or complicating ear-related conditions in hearing impaired adults.
A physical, "golden standard" ENT assessment was performed control group participants after 3 months. Based on this assessment, participants were again divided into categories of simple hearing loss, severe/complicated hearing loss, and no hearing loss respectively. The "golden standard" ENT assessment at Month 3 was compared to the physical ENT assessment at baseline and diagnostic differences were registered.
Outcome measures: Sensitivity and specificity of the conventional physical ENT specialist assessment routine in identifying severe/complicated hearing loss and/or complicating ear-related conditions in hearing impaired adults.
Measured: Month 3
Remote vs. physical ENT assessment on correct diagnosis of severe/complicated hearing loss and/or complicating ear-related conditions.
Comparison of sensitivity and specificity of remote vs. physical ENT assessment on correct identification of severe/complicated hearing loss and/or complication ear-related conditions in hearing impaired adults (p-values for comparison).
Measured: Month 3
Secondary outcomes (6)
Patient-reported treatment effect
The Speech, Spatial- and Qualities of Hearing Scale questionnaire af hearing aid treatment (SSQ12B) provides a score correlated to the subjective hearing difficulty severity after hearing aid treatment is initiated.
Possible scores ranged from -5 (a worsening of conditions after HAs) to 5 (an improvement of conditions after HAs).
Measured: Month 3
Effect of hearing aid treatment
The International Outcome Inventory for Hearing Aids (IOI-HA) covers a minimal set of seven core outcome items. The items are practically oriented and comprise a mini-profile more than a scale.
Measured: Month 3
Patient-reported satisfaction
A validated 21-item questionnaire regarding patient satisfaction during and after project participation was administered.
The scale ranged from 1-5 (low scores were associated with dissatisfaction, high scores to a high level of satisfaction)
Measured: Month 1
Patient-reported satisfaction
A validated 21-item questionnaire regarding patient satisfaction during and after project participation was administered.
The scale ranged from 1-5 (low scores were associated with dissatisfaction, high scores to a high level of satisfaction)
Measured: Month 2
Patient-reported satisfaction
A validated 21-item questionnaire regarding patient satisfaction during and after project participation was administered.
The scale ranged from 1-5 (low scores were associated with dissatisfaction, high scores to a high level of satisfaction)
Measured: Month 3
HA usage time
Overall and average daily usage time (hours) was registered digitally from the hearing aids 3 months after treatment initiation.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start16 Mar 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1:1 three arm randomized, controlled trial.
- Masking
- None (open label)
- Enrolment
- 751 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lene Dahl Siggaard, Aalborg University Hospital
- Investigators
- Morten Hoegsbro, MD, PhD, MSc, Study director, Department of Otorhinolaryngology and Audiology, Aalborg University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154539
- Sponsor's protocol ID
- InHEAR
- Acronym
- InHEAR
- Status last verified
- Jul 2022
- First submitted
- 14 Nov 2021
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siggaard LD, Jacobsen H, Hougaard DD, Hogsbro M. Digital vs. physical ear-nose-and-throat specialist assessment screening for complicated hearing loss and serious ear disorders in hearing-impaired adults prior to hearing aid treatment: a randomized controlled trial. Front Digit Health. 2023 Jun 8;5:1182421. doi: 10.3389/fdgth.2023.1182421. eCollection 2023.
PubMed 37363275
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovation of Hearing Rehabilitation and Effects of Reform
- ClinicalTrials.gov ID
- NCT05154539
- Acronym / sponsor ID
- InHEAR / InHEAR
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 751 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 13 Dec 2021 (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 Danish health care system has been criticized for its structural inefficiency and latency to initiate proper hearing rehabilitation amongst hearing-impaired individuals. Waiting lists are extensive, and audiometries are repeated before hearing aid treatment is initiated. Demographic changes forecast increasing numbers of +65-year-olds and consequently increased demand for hearing rehabilitation. To remedy this situation, the Danish Ministry of Health has proposed a new national initiative to implement innovative digital approaches to improve hearing rehabilitation, including a new, digital remote assessment routine.
The aim of this study is to investigate:
Primarily:
- Patient safety of remote vs. conventional assessment
- Patient-reported satisfaction and treatment effect of remote vs. conventional assessment Secondarily:
- Inter-subspecialty and inter-personal assessment differences between four ENT specialists using a remote assessment routine
- Translation and validation of the Danish adapted version of the Consumer Ear Disease Risk Assessment (CEDRA) questionnaire.
The main study is a randomized clinical trial with three arms and 1:1:1 assignment comprising 751 potential first-time adult hearing aid users.
Since March 2021, 751 patients have been randomized and assigned to 20 different clinics. The remote assessment routine works well for both patients, assessors, and clinics. Inclusion is expected to end in December 2021 and overall study completion is anticipated in april 2022.
Deficient diagnosis of complicating conditions in first time hearing aid users is the main concern in remote assessment. If the study shows the practice to be safe, it could form the foundation of a future nationwide implementation of remote care in Danish hearing rehabilitation.
Detailed description
InHEAR is a prospective randomized controlled trial aimed to investigate a new, Danish digital remote assessment routine applied in 751 hearing-impaired adults. The existing, traditional Danish referral model requires a physical consultation with an ear-nose- and throat (ENT) specialist prior to treatment initiation. The digital referral reform replaces the traditional physical ENT specialist assessment with a standardized examination package performed by educated and experienced audiology assistants, allowing physicians to assess and refer hearing-impaired adults to the relevant treatment regime remotely and asynchronously without meeting the patients physically.
After inclusion, the participants will be randomized equally into three groups:
Test group 1 (TG1) will be testing the digital assessment routine in private hearing clinics.
Test group 2 (TG2) will be testing the digital assessment routine in public hearing clinics.
Control group 3 (CG3) will be assessed in accordance with current Danish practice.
The examination package performed on test group participants comprises of:
- A standardized, focused medical hearing history record (questionnaire)
- A standard audiometry test, including air conduction, bone conduction, speech discrimination test and acoustic reflex test
- Tympanometry
- Still images of the eardrums performed by video-otoscopy
Four ENT-specialists, two audiologists and to private ENT specialist, will independently and remotely assess the standardized test group examination packages and refer the test group participants to relevant treatment. Participants in the control group are assessed by a private ENT specialist at a physical consultation and referred to relevant treatment in accordance with current Danish practice. Participants with simple hearing loss will be offered hearing rehabilitation with hearing aids. Participants with complicated hearing loss or complicated ear related diseases will be offered a physical ENT specialist assessment at the Department of Audiology at Aalborg University Hospital prior to treatment initiation.
Patient-reported data concerning treatment satisfaction-, quality- and effect will be registered throughout the study period.
Two-three months after treatment initiation, all participants are evaluated by an ENT specialist in Audiology or Otology at a "golden standard" physical consultation at the Department of Audiology at Aalborg University Hospital. Assessment and referral accuracy, patient-reported treatment quality and satisfaction between the test groups and the control group participants will be compared.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1:1:1 three arm randomized, controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Test Group 1 (TG1) | Experimental | Diagnostic Test: Remote digital assessmentTG1 participants are testing the new digital assessment routine in a private setting. Audiology assistants in private hearing clinics located in the Region of Northern Jutland in Denmark are performing the standardized examination packages. The private hearing clinics also conduct hearing aid treatment for TG1 participants with simple hearing loss. TG21 participants with complicated hearing loss or ear-related diseases are referred to the Department of Audiology at Aalborg University Hospital for further examination prior to treatment initiation. |
| Test Group 2 (TG2) | Experimental | Diagnostic Test: Remote digital assessmentTG2 participants are testing the new digital assessment routine in a public setting. Audiology assistants in public hearing clinics located in the Region of Northern Jutland in Denmark are performing the standardized examination packages. The public hearing clinics also conduct hearing aid treatment for TG2 participants with simple hearing loss. TG2 participants with complicated hearing loss or ear-related diseases are referred to the Department of Audiology at Aalborg University Hospital for further examination prior to treatment initiation. |
| Control Group 3 (CG3) | Active comparator | Diagnostic Test: Conventional physical assessmentCG3 participants will be assessed conventionally by a private practicing ENT specialist in the Region of Northern Jutland in Denmark at physical consultation in accordance with current Danish practice. CG3 participants with simple hearing loss can choose whether hearing aid treatment should be conducted in either a private or a public hearing clinic. CG3 participants with complicated hearing loss or ear-related diseases are referred to the Department of Audiology at Aalborg University Hospital for further examination prior to treatment initiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjective hearing difficulty
- Must be able to understand and read Danish
Key exclusion criteria (2 listed)
- Recent ENT specialist assessment
- Prior HA usage
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 |
|---|---|---|
| Remote digital assessmentRemote digital assessment of test group participants | Diagnostic test | Test Group 1 (TG1), Test Group 2 (TG2) |
| Conventional physical assessmentConventional physical assessment of control group participants | Diagnostic test | Control Group 3 (CG3) |
Primary outcome
Diagnosis of complicating hearing and/or ear-related conditions in hearing impaired adults
Time frame: Baseline
ENT specialist assessments were performed remotely in test group participants and physically in control group participants at baseline. Based on this assessment, participants were divided into three categories of simple hearing loss, severe/complicated hearing loss, and no hearing loss respectively. Hearing aid treatment was administered when indicated. The primary focus was to correctly identify participants with severe/complicated hearing loss and/or complicating ear-related conditions in both test and control groups.
Remote ENT specialist assessment: Diagnostic accuracy of severe/complicated hearing loss and/or complicating ear-related conditions in hearing impaired adults.
Time frame: Month 3
A physical, "golden standard" ENT assessment was performed in all test group participants after 3 months. Based on this assessment, participants were again divided into categories of simple hearing loss, severe/complicated hearing loss, and no hearing loss respectively. The "golden standard" ENT assessment at Month 3 was compared to the remote ENT assessment at baseline and diagnostic differences were registered. Outcome measures: Sensitivity and specificity of the remote ENT specialist assessment routine in identifying severe/complicated hearing loss and/or complicating ear-related conditions in hearing impaired adults.
Conventional, physical ENT specialist assessment: Diagnostic accuracy of severe/complicated hearing loss and/or complicating ear-related conditions in hearing impaired adults.
Time frame: Month 3
A physical, "golden standard" ENT assessment was performed control group participants after 3 months. Based on this assessment, participants were again divided into categories of simple hearing loss, severe/complicated hearing loss, and no hearing loss respectively. The "golden standard" ENT assessment at Month 3 was compared to the physical ENT assessment at baseline and diagnostic differences were registered. Outcome measures: Sensitivity and specificity of the conventional physical ENT specialist assessment routine in identifying severe/complicated hearing loss and/or complicating ear-related conditions in hearing impaired adults.
Remote vs. physical ENT assessment on correct diagnosis of severe/complicated hearing loss and/or complicating ear-related conditions.
Time frame: Month 3
Comparison of sensitivity and specificity of remote vs. physical ENT assessment on correct identification of severe/complicated hearing loss and/or complication ear-related conditions in hearing impaired adults (p-values for comparison).
6 secondary outcomes
Patient-reported treatment effect
Time frame: Month 3
Effect of hearing aid treatment
Time frame: Month 3
Patient-reported satisfaction
Time frame: Month 1
Patient-reported satisfaction
Time frame: Month 2
Patient-reported satisfaction
Time frame: Month 3
HA usage time
Time frame: Month 3
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 25 Jul 2022.
- Derived from this study: PubMed 37363275Siggaard LD, Jacobsen H, Hougaard DD, Hogsbro M. Digital vs. physical ear-nose-and-throat specialist assessment screening for complicated hearing loss and serious ear disorders in hearing-impaired adults prior to hearing aid treatment: a randomized controlled trial. Front Digit Health. 2023 Jun 8;5:1182421. doi: 10.3389/fdgth.2023.1182421. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Morten Hoegsbro, MD, PhD, MSc study director
Department of Otorhinolaryngology and Audiology, Aalborg University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote digital assessment and Conventional physical assessment in people with Hearing Loss, run by Aalborg University Hospital at 1 site in Denmark.
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 2 inclusion and 2 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 25 Jul 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 Denmark. 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?
Diagnosis of complicating hearing and/or ear-related conditions in hearing impaired adults (time frame: Baseline). The study lists 4 primary outcomes in all. 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 NCT05154539, which also lists 1 linked publication.
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 25 Jul 2022.