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Role of Exposure in Hyperacusis

Primary Purpose

Hyperacusis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Psychoeducation
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperacusis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Antwerp

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psychoeducation

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Tinnitus Functional Index (TFI)
Tinnitus severity self-report questionnaire, ranging from 0-100 with a higher score representing a more severe tinnitus

Full Information

First Posted
November 4, 2020
Last Updated
May 9, 2023
Sponsor
University Hospital, Antwerp
Collaborators
Universiteit Antwerpen
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1. Study Identification

Unique Protocol Identification Number
NCT04705246
Brief Title
Role of Exposure in Hyperacusis
Official Title
Effect of Psychoeducation Upon Exposure to Sounds and Hyperacusis Severity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 7, 2024 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Antwerp
Collaborators
Universiteit Antwerpen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperacusis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psychoeducation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in EMA questions from baseline to end of the study
Description
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 Outcome Measure Information:
Title
Hyperacusis Questionnaire
Description
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
Title
Tinnitus Functional Index (TFI)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laure Jacquemin, PhD
Phone
038214233
Email
laure_jacquemin@uza.be
Facility Information:
Facility Name
University Hospital Antwerp
City
Antwerp
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laure Jacquemin, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22443320
Citation
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.
Results Reference
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PubMed Identifier
28448659
Citation
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.
Results Reference
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PubMed Identifier
28669224
Citation
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.
Results Reference
background
PubMed Identifier
20515235
Citation
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.
Results Reference
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Role of Exposure in Hyperacusis

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