Exploratory Study on the Role of Somatic Modulation in Hyperacusis

NCT04693819 | Completed

• 1 other identifier: SomHyp
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperacusis

Keywords

Hyperacusis; Somatic; Modulation

Outcome Measures

Primary Outcomes (1)

• Change in rating of hyperacusis (loudness and intrusiveness) after modulation

  Change in hyperacusis loudness and intrusiveness rating by use of a visual analogue scale

  Baseline (Before modulation), Immediately after modulation

Secondary Outcomes (1)

• Change in rating of tinnitus (loudness and intrusiveness) after modulation

  Baseline (Before modulation), Immediately after modulation

Study Arms (1)

Hyperacusis

Abnormally reduced tolerance to sound

Diagnostic Test: Somatic modulation

Interventions

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

Hyperacusis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Primary complaint of hyperacusis

You may not qualify if:

• Primary complaint of tinnitus

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

University Hospital Antwerp

Antwerp, 2018, Belgium

Location

Related Publications (4)

• Shore SE. Plasticity of somatosensory inputs to the cochlear nucleus--implications for tinnitus. Hear Res. 2011 Nov;281(1-2):38-46. doi: 10.1016/j.heares.2011.05.001. Epub 2011 May 18.

  PMID: 21620940 BACKGROUND

• Baguley DM, Hoare DJ. Hyperacusis: major research questions. HNO. 2018 May;66(5):358-363. doi: 10.1007/s00106-017-0464-3.

  PMID: 29392341 BACKGROUND

• Baguley DM. Hyperacusis. J R Soc Med. 2003 Dec;96(12):582-5. doi: 10.1177/014107680309601203. No abstract available.

  PMID: 14645606 BACKGROUND

• Demoen S, Michiels S, Gilles A, Vermeersch H, Joossen I, Vanderveken OM, Lammers MJW, Timmermans A, Van Rompaey V, Baguley D, Jacquemin L. Pilot study on the role of somatic modulation in hyperacusis. Eur Arch Otorhinolaryngol. 2023 Mar;280(3):1425-1435. doi: 10.1007/s00405-022-07695-y. Epub 2022 Oct 13.

  PMID: 36224398 DERIVED

MeSH Terms

Conditions

Hyperacusis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 5, 2021
• Study Start: December 7, 2020
• Primary Completion: August 19, 2021
• Study Completion: December 31, 2021
• Last Updated: April 5, 2022

Record last verified: 2020-12

Locations

BE (1)