跳至主要内容
临床试验/NCT02177890
NCT02177890已完成不适用

Effect of Transcutaneous Vagal Nerve Stimulation on Reducing Visually Induced Motion Sickness in Healthy Volunteers

Wingate Institute of Neurogastroenterology2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2014年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
2
主要终点
Reduction of the subjective sensation of nausea on a visual analogue scale

研究概览

简要总结

Nausea is a common and distressing experience that often precedes vomiting. Amongst symptoms emanating from the gastrointestinal (GI) tract nausea can be considered somewhat unique, as on one hand it represents a normal, highly conserved, physiological response to an ingested toxin yet on the other it may indicate pathology. Nausea may also arise as a consequence of pharmaco- and chemotherapeutic interventions. Nausea negatively impacts on quality of life, adherence to treatment and is a cause for discontinuation of the development of novel compounds. Experimentally, nausea can be induced in humans using a visually induced motion stimulus. Previously we have developed a 10-minute motion video of the landscape rotating as seen from the perspective of a subject standing on Westminster Bridge, London. The tilted and rotating view visual display makes the subject perceive that they are spinning round and round on a spot tilted away from centre of gravity due to circular vection. This motion video induced nausea in approximately 50% of healthy participants and caused a reduction in cardiac vagal tone, a validated measure of the parasympathetic nervous system branch on the autonomic nervous system. We therefore are evaluating the role of external transcutaneous vagal nerve stimulation in visually induced motion sickness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects, aged 18-65, from staff, students and local population of Queen Mary, University of London.
  • Inclusion will be determined on the basis of availability, with no prior selection bias included. They should be able to attend the Wingate Institute for at least 2 x 1 hour sessions.
  • Subjects who score >15 on MSSQ (suggesting that they are sensitive to visually induced nausea).

排除标准

  • Subjects unable to provide informed consent.
  • Subjects with any systemic disease or medications that may influence the autonomic nervous system (e.g. beta-agonists or Parkinson's disease).
  • Subjects who score <15 on MSSQ (suggesting that they are insensitive to visually induced nausea).
  • Pregnant females to prevent any confounding effects on pregnancy related nausea.

结局指标

主要结局

Reduction of the subjective sensation of nausea on a visual analogue scale

时间窗: 10 minutes

次要结局

  • Effect of transcutaneous vagal nerve stimulation on cardiac vagal tone(10 minutes)
  • Tolerability of transcutaneous vagal nerve stimulation(10 minutes)

研究者

发起方
Wingate Institute of Neurogastroenterology
申办方类型
Other
责任方
Principal Investigator
主要研究者

Adam Farmer

Research fellow

Wingate Institute of Neurogastroenterology

研究点 (2)

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