NCT04705246

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
24mo left

Started Dec 2027

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
6.9 years until next milestone

Study Start

First participant enrolled

December 7, 2027

Expected
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

November 4, 2020

Last Update Submit

April 28, 2026

Conditions

Hyperacusis

Outcome Measures

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

    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

    before intervention, immediately post intervention

  • Tinnitus Functional Index (TFI)

    before intervention, immediately post intervention

Study Arms (1)

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.

Behavioral: Psychoeducation

Interventions

PsychoeducationBEHAVIORAL

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.

Psychoeducation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary complaint of hyperacusis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 22443320BACKGROUND

  • 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.

    PMID: 28448659BACKGROUND

  • 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.

    PMID: 28669224BACKGROUND

  • 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.

    PMID: 20515235BACKGROUND

MeSH Terms

Conditions

Hyperacusis

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Laure Jacquemin, PhD

CONTACT

038214233laure_jacquemin@uza.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2020

First Posted

January 12, 2021

Study Start (Estimated)

December 7, 2027

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2029

Last Updated

April 29, 2026

Record last verified: 2026-04