ClinicalTrials.gg
Not yet recruitingNCT04705246Updated Apr 29, 2026

Role of Exposure in Hyperacusis

An interventional study of Psychoeducation in Hyperacusis, sponsored by University Hospital, Antwerp. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by University Hospital, Antwerp · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

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Conditions studied

  • Hyperacusis

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03

In context

Hyperacusis

32 studies on the registry are indexed under Hyperacusis; 9 are open to participants now.

This study's planned enrollment of 5 is below the median of 60 across 22 interventional studies indexed under Hyperacusis.

Browse Hyperacusis studies →

Lead sponsor

University Hospital, Antwerp is the lead sponsor of 242 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • primary complaint of hyperacusis

Exclusion criteria

Exclusion Criteria:

  • primary complaint of misophonia
  • primary complaint of tinnitus
  • undergoing another therapy at the moment of the study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (estimated)

Study arms

  • Experimental
    Psychoeducation

    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.

    Behavioral: Psychoeducation

Interventions

  • BehavioralPsychoeducation

    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.

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What researchers measure

Primary outcomes

  1. 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

    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

Secondary outcomes

  1. 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.

    Time frame: before intervention, immediately post intervention

  2. Tinnitus Functional Index (TFI)

    Tinnitus severity self-report questionnaire, ranging from 0-100 with a higher score representing a more severe tinnitus

    Time frame: before intervention, immediately post intervention

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Study locations

No study locations are listed for this record.

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References and documents

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 22443320 ↗
  • Goldberg 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 28448659 ↗
  • Henry 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 28669224 ↗
  • Kratochwill 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 ↗

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2027; primary completion for Dec 2028, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 4, 2020
First posted
Jan 12, 2021
StartEst.
Dec 7, 2027
Primary completionEst.
Dec 2028
CompletionEst.
Dec 2029
Last update
Apr 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04705246
Responsible party
Sponsor
First posted
Jan 12, 2021
Start date
Dec 7, 2027 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Dec 2029 (estimated)
Last update
Apr 29, 2026

Study contacts

Laure Jacquemin, PhD
Contact
laure_jacquemin@uza.be
038214233

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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