HyperacusisNCT04705246
Role of Exposure in Hyperacusis
A study testing Psychoeducation in people with Hyperacusis, run by University Hospital, Antwerp.
Trial summary
This study focuses on patients with a primary complaint of hyperacusis. Hyperacusis has been defined as 'abnormally reduced tolerance to sound'. It shows a high comorbidity with tinnitus, the perception of sound in the absence of a sound source. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperacusis
- What is being tested?
- Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 7 Dec 2027to Dec 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary complaint of hyperacusis
Who cannot join
- primary complaint of misophonia
- primary complaint of tinnitus
- undergoing another therapy at the moment of the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Psychoeducation Upon Exposure to Sounds and Hyperacusis Severity
This study focuses on patients with a primary complaint of hyperacusis. Hyperacusis has been defined as 'abnormally reduced tolerance to sound'. It shows a high comorbidity with tinnitus, the perception of sound in the absence of a sound source. For the period of one month, hyperacusis and tinnitus severity and exposure to sounds will be evaluated by use of Ecological Momentary Assessment (EMA) in all participants. A novel approach to assessments, EMA prompts participants during their daily life to answer short questionnaires, increasing ecological validity and minimizing the risk for recall and memory biases. At a randomized time point during the one-month period, participants will individually receive a single psychoeducation session (1h) delivered by an experienced audiologist. The goal of the study is to investigate if the psychoeducation session leads to an increase in exposure to sound and a decrease in hyperacusis severity.
- Conditions
- Hyperacusis
- Being tested
- Psychoeducation
- Medical subject headings
- Hyperacusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
The goal of the psychoeducation session is to provide insight in the hyperacusis symptoms, take away the fear of external noises, and encourage exposure to noise.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation | Experimental | The goal of the psychoeducation session is to provide insight in the hyperacusis symptoms, take away the fear of external noises, and encourage exposure to noise. Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EMA questions from baseline to end of the study
Change in questions concerning exposure, hyperacusis and tinnitus during the day from baseline measurement to last day of the study period
Measured: 8 random time points each day during the period of the study, from baseline and after intervention, though study completion for an average of 1 month
Secondary outcomes (2)
Hyperacusis Questionnaire
Hyperacusis severity self-report questionnaire, ranging from 0-42 with a higher score representing a higher sensitivity to sounds. A score of 28 is the cut-off for auditory hypersensitivity.
Measured: before intervention, immediately post intervention
Tinnitus Functional Index (TFI)
Tinnitus severity self-report questionnaire, ranging from 0-100 with a higher score representing a more severe tinnitus
Measured: before intervention, immediately post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start7 Dec 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HyperacusisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705246
- Sponsor's protocol ID
- Exposure in Hyperacusis
- Status last verified
- Apr 2026
- First submitted
- 4 Nov 2020
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Blaesing L, Kroener-Herwig B. Self-reported and behavioral sound avoidance in tinnitus and hyperacusis subjects, and association with anxiety ratings. Int J Audiol. 2012 Aug;51(8):611-7. doi: 10.3109/14992027.2012.664290. Epub 2012 Mar 24.
PubMed 22443320Goldberg RL, Piccirillo ML, Nicklaus J, Skillington A, Lenze E, Rodebaugh TL, Kallogjeri D, Piccirillo JF. Evaluation of Ecological Momentary Assessment for Tinnitus Severity. JAMA Otolaryngol Head Neck Surg. 2017 Jul 1;143(7):700-706. doi: 10.1001/jamaoto.2017.0020.
PubMed 28448659Henry JA, Thielman E, Zaugg T, Kaelin C, Choma C, Chang B, Hahn S, Fuller B. Development and field testing of a smartphone "App" for tinnitus management. Int J Audiol. 2017 Oct;56(10):784-792. doi: 10.1080/14992027.2017.1338762. Epub 2017 Jul 2.
PubMed 28669224Kratochwill TR, Levin JR. Enhancing the scientific credibility of single-case intervention research: randomization to the rescue. Psychol Methods. 2010 Jun;15(2):124-44. doi: 10.1037/a0017736.
PubMed 20515235
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Psychoeducation Upon Exposure to Sounds and Hyperacusis Severity
- ClinicalTrials.gov ID
- NCT04705246
- Acronym / sponsor ID
- Exposure in Hyperacusis
- Conditions
- Hyperacusis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen
- Study start
- 7 Dec 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 12 Jan 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.
This study focuses on patients with a primary complaint of hyperacusis. Hyperacusis has been defined as 'abnormally reduced tolerance to sound'. It shows a high comorbidity with tinnitus, the perception of sound in the absence of a sound source. For the period of one month, hyperacusis and tinnitus severity and exposure to sounds will be evaluated by use of Ecological Momentary Assessment (EMA) in all participants. A novel approach to assessments, EMA prompts participants during their daily life to answer short questionnaires, increasing ecological validity and minimizing the risk for recall and memory biases. At a randomized time point during the one-month period, participants will individually receive a single psychoeducation session (1h) delivered by an experienced audiologist. The goal of the study is to investigate if the psychoeducation session leads to an increase in exposure to sound and a decrease in hyperacusis severity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation | Experimental | Behavioral: PsychoeducationThe goal of the psychoeducation session is to provide insight in the hyperacusis symptoms, take away the fear of external noises, and encourage exposure to noise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary complaint of hyperacusis
Key exclusion criteria (3 listed)
- primary complaint of misophonia
- primary complaint of tinnitus
- undergoing another therapy at the moment of the study
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 |
|---|---|---|
| PsychoeducationThe goal of the psychoeducation session is to provide insight in the hyperacusis symptoms, take away the fear of external noises, and encourage exposure to noise. | Behavioural | Psychoeducation |
Primary outcome
Change in EMA questions from baseline to end of the study
Time frame: 8 random time points each day during the period of the study, from baseline and after intervention, though study completion for an average of 1 month
Change in questions concerning exposure, hyperacusis and tinnitus during the day from baseline measurement to last day of the study period
2 secondary outcomes
Hyperacusis Questionnaire
Time frame: before intervention, immediately post intervention
Tinnitus Functional Index (TFI)
Time frame: before intervention, immediately 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 29 Apr 2026.
- Background: PubMed 22443320Blaesing L, Kroener-Herwig B. Self-reported and behavioral sound avoidance in tinnitus and hyperacusis subjects, and association with anxiety ratings. Int J Audiol. 2012 Aug;51(8):611-7. doi: 10.3109/14992027.2012.664290. Epub 2012 Mar 24.
- Background: PubMed 28448659Goldberg RL, Piccirillo ML, Nicklaus J, Skillington A, Lenze E, Rodebaugh TL, Kallogjeri D, Piccirillo JF. Evaluation of Ecological Momentary Assessment for Tinnitus Severity. JAMA Otolaryngol Head Neck Surg. 2017 Jul 1;143(7):700-706. doi: 10.1001/jamaoto.2017.0020.
- Background: PubMed 28669224Henry JA, Thielman E, Zaugg T, Kaelin C, Choma C, Chang B, Hahn S, Fuller B. Development and field testing of a smartphone "App" for tinnitus management. Int J Audiol. 2017 Oct;56(10):784-792. doi: 10.1080/14992027.2017.1338762. Epub 2017 Jul 2.
- Background: PubMed 20515235Kratochwill TR, Levin JR. Enhancing the scientific credibility of single-case intervention research: randomization to the rescue. Psychol Methods. 2010 Jun;15(2):124-44. doi: 10.1037/a0017736.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation in people with Hyperacusis, run by University Hospital, Antwerp.
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 3 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: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Laure Jacquemin, PhD (038214233, laure_jacquemin@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EMA questions from baseline to end of the study (time frame: 8 random time points each day during the period of the study, from baseline and after intervention, though study completion for an average of 1 month). 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 NCT04705246, which also lists 4 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 29 Apr 2026.