Role of Exposure in Hyperacusis

Sponsor
University Hospital, Antwerp (Other)
Overall Status
Recruiting
CT.gov ID
NCT04705246
Collaborator
Universiteit Antwerpen (Other)
5
1
1
23.8
0.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Psychoeducation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Psychoeducation Upon Exposure to Sounds and Hyperacusis Severity
Actual Study Start Date :
Dec 7, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Antwerp Antwerp Belgium

Sponsors and Collaborators

  • University Hospital, Antwerp
  • Universiteit Antwerpen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT04705246
Other Study ID Numbers:
  • Exposure in Hyperacusis
First Posted:
Jan 12, 2021
Last Update Posted:
Apr 5, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2022