Effect of Transcutaneous Vagal Nerve Stimulation on Reducing Visually Induced Motion Sickness in Healthy Volunteers
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
- 是
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
Adam Farmer
Research fellow
Wingate Institute of Neurogastroenterology
