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CompletedNCT04693819Updated Apr 5, 2022

Exploratory Study on the Role of Somatic Modulation in Hyperacusis

An observational study in Hyperacusis, sponsored by University Hospital, Antwerp. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-05.

Sponsored by University Hospital, Antwerp · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
18
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Hyperacusis

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Keywords

  • Hyperacusis
  • Somatic
  • Modulation
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In context

Hyperacusis

32 studies on the registry are indexed under Hyperacusis; 9 are open to participants now.

Browse Hyperacusis studies →

Lead sponsor

University Hospital, Antwerp is the lead sponsor of 242 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Primary complaint of hyperacusis

Exclusion criteria

Exclusion Criteria:

  • Primary complaint of tinnitus
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
18 participants (actual)
Patient registry
No

Groups and cohorts

  • Hyperacusis

    Abnormally reduced tolerance to sound

    Diagnostic Test: Somatic modulation

Interventions

  • Diagnostic testSomatic 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

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What researchers measure

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

    Time frame: Baseline (Before modulation), Immediately after modulation

Secondary outcomes

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

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

    Time frame: Baseline (Before modulation), Immediately after modulation

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Study locations

1 site
  • University Hospital Antwerp
    Antwerpen, 2018, Belgium
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References and documents

Publications

  • 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. PubMed 21620940 ↗
  • Baguley DM, Hoare DJ. Hyperacusis: major research questions. HNO. 2018 May;66(5):358-363. doi: 10.1007/s00106-017-0464-3. PubMed 29392341 ↗
  • Baguley DM. Hyperacusis. J R Soc Med. 2003 Dec;96(12):582-5. doi: 10.1177/014107680309601203. No abstract available. PubMed 14645606 ↗
  • 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. PubMed 36224398 ↗

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2020 to primary completion in Aug 2021, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 30, 2020
First posted
Jan 5, 2021
StartActual
Dec 7, 2020
Primary completionActual
Aug 19, 2021
CompletionActual
Dec 31, 2021
Last update
Apr 5, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04693819
Responsible party
Sponsor
First posted
Jan 5, 2021
Start date
Dec 7, 2020
Primary completion
Aug 19, 2021
Completion
Dec 31, 2021
Last update
Apr 5, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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