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Completed

NCT Number: NCT04693819

Exploratory Study on the Role of Somatic Modulation in Hyperacusis

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.

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Key information

Conditions

Hyperacusis Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Antwerp

Antwerp, 2018, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary complaint of hyperacusis

Exclusion criteria

  • Primary complaint of tinnitus

Treatment and study plan

Somatic modulation

Diagnostic Test

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2021
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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