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Role of Exposure in Hyperacusis

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ClinicalTrials.gov Identifier: NCT04705246
Recruitment Status : Recruiting
First Posted : January 12, 2021
Last Update Posted : January 12, 2021
Sponsor:
Collaborator:
Universiteit Antwerpen
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hyperacusis Behavioral: Psychoeducation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 7, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

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.




Primary Outcome Measures :
  1. Change in EMA questions from baseline to end of the study [ 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 ]
    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 [ Time Frame: 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) [ Time Frame: before intervention, immediately post intervention ]
    Tinnitus severity self-report questionnaire, ranging from 0-100 with a higher score representing a more severe tinnitus



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04705246


Contacts
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Contact: Laure Jacquemin, PhD 038214233 laure_jacquemin@uza.be

Locations
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Belgium
University Hospital Antwerp Recruiting
Antwerp, Belgium
Contact: Laure Jacquemin, PhD         
Sponsors and Collaborators
University Hospital, Antwerp
Universiteit Antwerpen
Publications:
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Responsible Party: University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT04705246    
Other Study ID Numbers: Exposure in Hyperacusis
First Posted: January 12, 2021    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperacusis
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases