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临床试验/NCT07446348
NCT07446348尚未招募不适用

The Effect of Nitrogen Narcosis on Motor Performance in Divers Who Have Sustained an Inner Ear Decompression Illness

University of Plymouth0 个研究点目标入组 40 人开始时间: 2026年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
主要终点
Presence of Nystagmus

研究概览

简要总结

Nitrogen starts to have narcotic properties depths below 30m and can cause symptoms such as euphoria, impaired judgement and impaired neuromuscular coordination. This is an important safety and performance consideration for divers working at depth. 'Dry dive' experiences (also known as 'pot dives') are frequently run by DDRC Healthcare for dive clubs or students who wish to experience nitrogen narcosis and the effects of pressure in a more controlled environment than underwater. The purpose of this study is to investigate the effect of this narcotic effect on oculomotor, vestibular and motor performance by asking participants to perform tasks whilst in the chamber at depth. There will be two groups of participants - those who have had no previous decompression illness or issues with their balance/ inner ear, and divers who have previously sustained an inner ear decompression sickness (IEDCS). It is theorised that divers who have previously sustained an IEDCS injury will struggle more with tasks involving balance and co-ordination under the effect of narcosis. This is because around 60% of divers with IEDCS will have some long-lasting damage to their inner ear and nitrogen narcosis impairs areas of the brain that are being used to compensate for the injury. Therefore, it is possible that inner ear symptoms such as dizziness or disorientation may recur temporarily whilst at depth. Understanding if these divers are at risk will help guide safety advice for returning to diving in the water after an IEDCS injury. If participants decide to take part, they will be asked to complete a medical screening form to ensure that they are safe to undertake a dive in the chamber. They will also be sent some information by DDRC Healthcare including a disclaimer/ consent form which will outline any potential risks or considerations regarding the dive. When participants attend DDRC Healthcare for the planned 'dry' dive they will be shown around the chamber room, and the procedure will be explained. They may ask questions at any point if they have any queries or concerns. The whole session including the dive will take up to 2 hours in total. Prior to entering the chamber, participants will have electrodes attached to areas on their face, head and neck. These will track hand and eye movement and postural stability. Once comfortable, participants will enter the chamber, inside they will be accompanied by a researcher/dive doctor and a chamber attendant. Before the chamber is compressed participants will be asked to perform a series of tasks that the researcher will assist with. The chamber will then be compressed to the equivalent of 40m for a maximum time of 10 minutes, at 40m the series of tasks will be repeated. The chamber will then be slowly decompressed to 6m and then to 3m giving a total time of 36 minutes for the whole dive. For the last 18 minutes participants will breathe oxygen from a mask. Once at surface the series of tasks will be repeat for a third time. Tasks: 1) Recording of eye movements: a. Looking forward with eyes closed b. Following a moving target on a screen c. Looking forward whilst head is moved from left to right by researcher 2) 9-hole peg test (placing pegs into a board and then removing them again) 3) Finger to nose test (pointing to and from a target on a screen and nose) 4) Trial making test (paper and pencil test identifying a sequenced pattern) 5) Postural sway (standing with feet together with eyes open and then closed).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • '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.

排除标准

  • 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)

研究组 & 干预措施

'Healthy' participants with no prior decompression illness or inner ear/balance conditions

干预措施: Nitrogen-oxygen breathing mixture (Drug)

Divers with prior inner ear decompression illness

干预措施: Nitrogen-oxygen breathing mixture (Drug)

结局指标

主要结局

Presence of Nystagmus

时间窗: During hyperbaric dive (30 seconds)

Present or absent on EOG recording

Direction of Nystagmus

时间窗: 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

Speed of Nystagmus

时间窗: 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

Assessment of visual smooth pursuit tracking a sinusoidal target

时间窗: During hyperbaric dive (60 seconds)

Measure of gain (%) of eye movement on EOG recording

Hand co-ordination - time to complete 9 hole peg test

时间窗: During hyperbaric dive (60 seconds maximum)

Time to place all 9 pins and remove all 9 pins measured in seconds

Hand co-ordination - mean jerk of wrist during 9 hole peg test

时间窗: 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)

Finger to nose co-ordination - error to target

时间窗: During hyperbaric dive (45 seconds)

Absolute error to target (cm) measured using co-ordinates on touch screen

Finger to nose co-ordination - mean jerk of wrist

时间窗: 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)

Trail making test - total time for completion

时间窗: During hyperbaric dive (90 seconds maximum)

Time Trail Test A and Trail Test B take to complete in seconds (A+B)

Postural sway - feet together eyes open - sagittal velocity

时间窗: 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)

Postural sway - feet together eyes open - coronal velocity

时间窗: 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)

Postural sway - feet together eyes closed - sagittal velocity

时间窗: 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)

Postural sway - feet together eyes closed - coronal velocity

时间窗: 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)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rosanna J Stokes

Diving & Hyperbaric Physician

University of Plymouth

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