The Effect of Nitrogen Narcosis on Motor Performance in Divers Who Have Sustained an Inner Ear Decompression Illness
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 'Healthy/normative' participants with no history of orthopaedic/ neurological disorders that could affect balance or cognition.
- Diver participants with a history of inner ear decompression illness, have returned to diving and have had a confirmed negative patent foramen ovale (PFO) screen or closure procedure.
Exclusion Criteria:
- History of substance abuse
- Excessive caffeine intake within 24 hours (1 cup coffee max.)
- Alcohol intake within 24 hours
- Known PFO
- IEDCS diver with residual severe vestibular/ balance symptoms (unable to stand with feet together and eyes closed for 30 seconds)
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
'Healthy' participants with no prior decompression illness or inner ear/balance conditions
|
Hyperbaric chamber dive exposing participants to hyperbaric nitrogen inducing a transitory nitrogen narcosis
|
|
Divers with prior inner ear decompression illness
|
Hyperbaric chamber dive exposing participants to hyperbaric nitrogen inducing a transitory nitrogen narcosis
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence of Nystagmus
Time Frame: During hyperbaric dive (30 seconds)
|
Present or absent on EOG recording
|
During hyperbaric dive (30 seconds)
|
|
Direction of Nystagmus
Time Frame: During hyperbaric dive (30 seconds)
|
If nystagmus is present the direction of the slow phase (up/down/left/right) will be recorded as seen on EOG recording
|
During hyperbaric dive (30 seconds)
|
|
Speed of Nystagmus
Time Frame: During hyperbaric dive (30 seconds)
|
If nystagmus is present the average speed of the nystagmus (in degrees per second) will be recorded as seen on EOG recording
|
During hyperbaric dive (30 seconds)
|
|
Assessment of visual smooth pursuit tracking a sinusoidal target
Time Frame: During hyperbaric dive (60 seconds)
|
Measure of gain (%) of eye movement on EOG recording
|
During hyperbaric dive (60 seconds)
|
|
Hand co-ordination - time to complete 9 hole peg test
Time Frame: During hyperbaric dive (60 seconds maximum)
|
Time to place all 9 pins and remove all 9 pins measured in seconds
|
During hyperbaric dive (60 seconds maximum)
|
|
Hand co-ordination - mean jerk of wrist during 9 hole peg test
Time Frame: During hyperbaric dive (60 seconds maximum)
|
Mean jerk of wrist during 9 hole peg test, measured by inertial sensors on wrist.
Jerk = sqrt(acceleration x2+ acceleration y2+ acceleration z2)
|
During hyperbaric dive (60 seconds maximum)
|
|
Finger to nose co-ordination - error to target
Time Frame: During hyperbaric dive (45 seconds)
|
Absolute error to target (cm) measured using co-ordinates on touch screen
|
During hyperbaric dive (45 seconds)
|
|
Finger to nose co-ordination - mean jerk of wrist
Time Frame: During hyperbaric dive (45 seconds)
|
Mean jerk of wrist during test measured using inertial sensor on wrist.
Where jerk = sqrt(acceleration x2+ acceleration y2+ acceleration z2)
|
During hyperbaric dive (45 seconds)
|
|
Trail making test - total time for completion
Time Frame: During hyperbaric dive (90 seconds maximum)
|
Time Trail Test A and Trail Test B take to complete in seconds (A+B)
|
During hyperbaric dive (90 seconds maximum)
|
|
Postural sway - feet together eyes open - sagittal velocity
Time Frame: During hyperbaric dive (30 seconds)
|
Mean angular velocity in sagittal direction over 30 seconds with feet together eyes open.
Measured using inertial sensors placed on C7 spinous process.
(degrees/second)
|
During hyperbaric dive (30 seconds)
|
|
Postural sway - feet together eyes open - coronal velocity
Time Frame: During hyperbaric dive (30 seconds)
|
Mean angular velocity in coronal direction over 30 seconds with feet together eyes open.
Measured using inertial sensors placed on C7 spinous process.
(degrees/second)
|
During hyperbaric dive (30 seconds)
|
|
Postural sway - feet together eyes closed - sagittal velocity
Time Frame: During hyperbaric dive (30 seconds)
|
Mean angular velocity in sagittal direction over 30 seconds with feet together eyes closed.
Measured using inertial sensors placed on C7 spinous process.
(degrees/second)
|
During hyperbaric dive (30 seconds)
|
|
Postural sway - feet together eyes closed - coronal velocity
Time Frame: During hyperbaric dive (30 seconds)
|
Mean angular velocity in coronal direction over 30 seconds with feet together eyes closed.
Measured using inertial sensors placed on C7 spinous process.
(degrees/second)
|
During hyperbaric dive (30 seconds)
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 7032 (CTEP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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