Hearing LossNCT06468137
Follow Up of an Online Hearing Support for First-time Hearing Aid Users
A study testing Swedish I-ACE, Clinical visit and No follow-up in people with Hearing Loss and Hearing Impairment, run by Region Skane at 1 site in Sweden.
Trial summary
The main questions the research aims to answer are short- and long-term effects on consequences of hearing loss depending on which type of follow-up the participant chooses. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hearing Loss, Hearing Impairment, Hearing Disorders
- What is being tested?
- Swedish I-ACE, Clinical visit and No follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jul 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People who have participated in NCT06051968 are automatically enrolled to participate in the follow-up according to the study protocol.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow Up of an Online Hearing Support for First-time Hearing Aid Users Using the Swedish I-ACE, Clinical Visit or Nothing
The main questions the research aims to answer are short- and long-term effects on consequences of hearing loss depending on which type of follow-up the participant chooses.
Read the detailed description
Investigation of the emotional and social consequences of hearing loss that the participants experience, use of communications strategies, experienced listening in complex sound environments and perceived effectiveness and satisfaction with hearing aids. The goal is also to assess changes in use of communication strategies and the emotional consequences, knowledge and acceptance of hearing loss.
- Conditions
- Hearing Loss, Hearing Impairment, Hearing Disorders
- Being tested
- Swedish I-ACE, Clinical visit, No follow-up
- Medical subject headings
- Hearing Loss, Hearing Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swedish I-ACEBehavioural
Rehabilitative programme with focus on communication strategies and problem solving for people with hearing loss.
Clinical visitBehavioural
Visit in the clinic with focus on audiologic rehabilitation.
No follow-upOther
Participants choosing no follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Swedish I-ACE | Other | Participants choosing to take part in the Swedish I-ACE as follow-up. Receives: Behavioral: Swedish I-ACE |
| Clinical visit | Other | Participants choosing a clinical visit as follow-up. Receives: Behavioral: Clinical visit |
| No follow-up | Other | Participants choosing no follow-up. Receives: Other: No follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Hearing Handicap Inventory for the Elderly (HHIE)
Assessing changes in emotional and social effects of hearing loss, self-perceived activity limitations and participation restrictions. Minimum 0 points to maximum 100 points. Higher score indicates greater emotional and social effects of hearing loss.
Measured: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
Secondary outcomes (5)
The 12-item Speech, Spatial and Qualities of Hearing Scale (SSQ12)
Assessing experience of listening in complex sound environments. Minimum 0 points to 120 points. Higher score indicates less problems with hearing in the specified situations.
Measured: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
Communication Strategies Scale (CSS)
Assessing changes in use of verbal, non-verbal and maladaptive communication strategies. Minimum 25 points to maximum 125 points. Higher score indicates a greater use of communication strategies.
Measured: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
The International Outcome Inventory for Hearing Aids (IOI-HA)
Assessing changes in perceived effectiveness and satisfaction with hearing aids.
Minimum 7 points to maximum 35 points. Higher score indicates higher perceived effect.
Measured: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
Communication and Acceptance Scale (CAS)
Assessing changes in use of communication strategies and the emotional consequences, knowledge and acceptance of hearing loss. Minimum 18 points to maximum 90. Higher score indicates a lower impact of the hearing loss.
Measured: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
The International Outcome Inventory for Alternative Interventions (IOI-AI)
Assessing changes in perceived effectiveness and satisfaction with an alternative intervention, in this case the Swedish I-ACE.
Minimum 7 points to maximum 35 points. Higher score indicates higher perceived effect.
Measured: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Horselvarden Region Ostergotland
- Responsible party
- Sponsor
- Investigators
- Marie Öberg, Principal investigator, Horselvarden Region Ostergotland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468137
- Sponsor's protocol ID
- Uppföljning
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow Up of an Online Hearing Support for First-time Hearing Aid Users Using the Swedish I-ACE, Clinical Visit or Nothing
- ClinicalTrials.gov ID
- NCT06468137
- Acronym / sponsor ID
- Uppföljning
- Conditions
- Hearing Loss, Hearing Impairment, Hearing Disorders
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Horselvarden Region Ostergotland
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Jun 2024 (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 main questions the research aims to answer are short- and long-term effects on consequences of hearing loss depending on which type of follow-up the participant chooses.
Detailed description
Investigation of the emotional and social consequences of hearing loss that the participants experience, use of communications strategies, experienced listening in complex sound environments and perceived effectiveness and satisfaction with hearing aids. The goal is also to assess changes in use of communication strategies and the emotional consequences, knowledge and acceptance of hearing loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Swedish I-ACE | Other | Behavioral: Swedish I-ACEParticipants choosing to take part in the Swedish I-ACE as follow-up. |
| Clinical visit | Other | Behavioral: Clinical visitParticipants choosing a clinical visit as follow-up. |
| No follow-up | Other | Other: No follow-upParticipants choosing no follow-up. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- People who have participated in NCT06051968 are automatically enrolled to participate in the follow-up according to the study protocol.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Swedish I-ACERehabilitative programme with focus on communication strategies and problem solving for people with hearing loss. | Behavioural | Swedish I-ACE |
| Clinical visitVisit in the clinic with focus on audiologic rehabilitation. | Behavioural | Clinical visit |
| No follow-upParticipants choosing no follow-up. | Other | No follow-up |
Primary outcome
The Hearing Handicap Inventory for the Elderly (HHIE)
Time frame: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
Assessing changes in emotional and social effects of hearing loss, self-perceived activity limitations and participation restrictions. Minimum 0 points to maximum 100 points. Higher score indicates greater emotional and social effects of hearing loss.
5 secondary outcomes
The 12-item Speech, Spatial and Qualities of Hearing Scale (SSQ12)
Time frame: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
Communication Strategies Scale (CSS)
Time frame: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
The International Outcome Inventory for Hearing Aids (IOI-HA)
Time frame: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
Communication and Acceptance Scale (CAS)
Time frame: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
The International Outcome Inventory for Alternative Interventions (IOI-AI)
Time frame: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- 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.
Marie Öberg principal investigator
Horselvarden Region Ostergotland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swedish I-ACE, Clinical visit and No follow-up in people with Hearing Loss and Hearing Impairment, run by Region Skane at 1 site in Sweden.
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 1 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
The Hearing Handicap Inventory for the Elderly (HHIE) (time frame: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention). 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 12 Aug 2026.