Role of Exposure in Hyperacusis

Not Applicable

Not yet recruiting

• Conditions: Hyperacusis

• Registration Number: NCT04705246
• Lead Sponsor: University Hospital, Antwerp

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-04
• Study First Submitted QC: 2021-01-11
• Study First Posted: 2021-01-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Study Start: 2025-12-07
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• primary complaint of hyperacusis

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in EMA questions from baseline to end of the study	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

Secondary Outcome Measures

Name	Time	Method
Hyperacusis Questionnaire	before intervention, immediately post intervention	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.
Tinnitus Functional Index (TFI)	before intervention, immediately post intervention	Tinnitus severity self-report questionnaire, ranging from 0-100 with a higher score representing a more severe tinnitus