Exploratory Study on the Role of Somatic Modulation in Hyperacusis

April 4, 2022 updated by: University Hospital, Antwerp
This study focuses on patients with a primary complaint of hyperacusis. Hyperacusis has been defined as 'abnormally reduced tolerance to sound' and is commonly associated with tinnitus. The effects of somatic modulation upon tinnitus have been studied, but not so for hyperacusis.. The effect of 9 somatic modulations (i.e. 3 jaw modulations and 6 cervical spine modulations) and 1 control movement (i.e. without any somatic modulation effect) in random order on the sound tolerance of a 1 kilohertz (kHz) broadband noise sound and the tinnitus experience will be investigated. More specifically, the perceived loudness and intrusiveness of this sound and the tinnitus sound will be evaluated before somatic modulation and during the somatic modulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2018
        • University Hospital Antwerp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will be aimed at adults experiencing a primary complaint of hyperacusis (i.e. abnormally reduced tolerance to sound).

Description

Inclusion Criteria:

  • Primary complaint of hyperacusis

Exclusion Criteria:

  • Primary complaint of tinnitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hyperacusis
Abnormally reduced tolerance to sound
Diagnostic test: Somatic modulation

Type of modulations: 3 jaw and 6 cervical spine modulations, 1 control movement (i.e. without any expected somatic modulation effect) Jaw modulations: laterotrusion to the left, laterotrusion to the right and protrusion Cervical spine modulations: isometric flexion, extension and left and right lateroflexion of the head against resistance of the investigator's hand, compression and traction of the cervical spine in sitting position.

Control movement: the investigator's hand rests against the patient's forehead without any force application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in rating of hyperacusis (loudness and intrusiveness) after modulation
Time Frame: Baseline (Before modulation), Immediately after modulation
Change in hyperacusis loudness and intrusiveness rating by use of a visual analogue scale
Baseline (Before modulation), Immediately after modulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in rating of tinnitus (loudness and intrusiveness) after modulation
Time Frame: Baseline (Before modulation), Immediately after modulation
Change in tinnitus loudness and intrusiveness rating by use of a visual analogue scale
Baseline (Before modulation), Immediately after modulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 7, 2020

Primary Completion (ACTUAL)

August 19, 2021

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

December 30, 2020

First Submitted That Met QC Criteria

December 31, 2020

First Posted (ACTUAL)

January 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SomHyp

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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