Prediction & Mechanisms of Recovery Following IEDS
ConditionDecompression Sickness
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorUniversity of Plymouth
About this trial
Inner Ear Decompression sickness (IEDS) accounts for 20% of all types of decompression sickness (the bends) in divers. The condition commonly affects the peripheral vestibular system (inner ear). IEDS results in acute symptoms of dizzyness (vertigo) and imbalance. Even with the recommended treatment of hyperbaric oxygen therapy some people do not recovery fully. However, even in the presence of a permanent vestibular deficit many people can show a behavioural recovery where symptoms improve over time. Recovery can be aided by vestibular rehabilitation (VR) which is now routine for acute IEDS but was not provided before 2021, and is not widespread across the UK (United Kingdom) or world, meaning people may have a suboptimal recovery.
This project will investigate if and how people recover after an acute episode of IEDS and whether people who had IEDS in the past show changes in the central (brain) processing of vestibular function and in symptoms of dizziness, balance and posture.
This project has two main parts. Part one is a prospective observational study where people with an acute onset of IEDS are serially monitored while they are receiving hyperbaric treatment and VR over 10-14 days. Part two is a retrospective observational study where who have had IEDS in the past 15 years are re-assessed in a one-off session. The tests in both parts involve clinical tests and specialist eye movement recordings that assess vestibular function. We will also determine the site of any vestibular pathology by using selective stimulation of the vestibular end organ or nerve and assess whether there are any changes in how the structure and function of central vestibular pathways in the brain. In people with chronic IEDS with vestibular symptoms we will offer participants a course of VR over 12 weeks and assess whether this is associated with any improvement in symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Medically unstable
Unstable orthopaedic deficits
Disqualifiers
None
Trial population
Population: Divers Exposure: Dive resulting in IEDS symptoms
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
41 Participants
are grouped into 2 trial groupsGroup A: Prospective Cohort
Group B: Retrospective Cohort
Trial outcomes
Primary outcomes
1
Side of peripheral vestibular damage: Prospective cohort
Side (left or right) of vestibular dysfunction as determine by video head impulse test (v HIT) testing
Time frame
T0=baseline within 24 hours of IEDS in the prospective cohort2
Site of peripheral vestibular damage: Prospective cohort
Site of dysfunction: semi-circular canals affected as determine by v HIT testing. One or a combination of Horizontal, anterior or posterior canals.
Time frame
T0=baseline within 24 hours of IEDS in the prospective cohort3
Extent of peripheral vestibular damage: Prospective cohort
VOR gain (unit less) as measured by v HIT at T0 (Range 0-1 higher values are better outcome)
Time frame
T0=baseline within 24 hours of IEDS in the prospective cohort4
Side of peripheral vestibular damage: Retrospective cohort
Side (left or right) of vestibular dysfunction as determine by video head impulse test (v HIT) testing
Time frame
1 time point: 0-10 years post injurySecondary outcomes
1
VOR gain v HIT: Prospective Study
Change from baseline (T0) in VOR gain assessed through V HIT test . Gain is unit less and range from 0-1 where higher values indicate a better clinical outcome.
Time frame
7-10 days , 3 months and 12 months post injury2
VOR gain: Prospective Study
Change from baseline (T0) in VOR gain assessed through sinusoidal rotation in the dark . Gain is unit less and range from 0-1 where higher values indicate a better clinical outcome.
Time frame
7-10 days , 3 months and 12 months post injury3
VOR Time constant:Prospective Study
Change from baseline (T0)in VOR time constant in response to a step rotation (initial 140°/s acceleration/deceleration and a 60°/s fixed-chair velocity) stimulus . Time constant (seconds) where a higher time constant is clinically better. Range 0-40s.
Time frame
7-10 days , 3 months and 12 months post injury4
Patient reported outcome measure: Prospective Study
Change from baseline (T0) in PROM (patient reported outcome measure) vertigo severity scale.15 questions rated 0-4. Score range =0-60 where lower scores indicate a better clinical outcome
Time frame
7-10 days , 3 months and 12 months post injuryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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