Effects of Sphenopalatine Ganglion Acupuncture on Nasal Ventilation and Autonomic Nervous Activity in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- The change of subjective perception nasal ventilation
研究概览
简要总结
Sphenopalatine ganglion (SPG)-acupuncture has been shown to exhibit distinct effects in treatment of nasal inflammatory disease, but the mechanisms remain largely unknown. Investigators aimed to assess the effects of SPG acupuncture for nasal ventilation function and autonomic nervous system in health volunteers. The randomized, double-blind, controlled clinical trial enrolled healthy volunteers.Healthy subjects were randomly assigned to either active SPG-acupuncture group or sham-acupuncture group. All subjects were assessed for self-reported nasal ventilation, nasal patency (nasal airway resistance (NAR) and nasal cavity volume (NVC)), exhaled nasal nitric oxide (nNO) before and after acupuncture. Meanwhile, in order to explore underlying mechanisms of SPG acupuncture, the changes in neuropeptides (substance P (SP), vasoactive intestinal peptide (VIP) and neuropeptide Y (NPY)) in nasal secretions were investigated at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •non-smoking volunteers
- •without history of nasal disease (allergic rhinitis, sinusitis, nasal polyps, nasal septum deviation and history of nose surgery) or lung disease (asthma, chronic obstructive pulmonary disease and fibrosis)
- •free of upper and lower respiratory tract infections for at least 4 weeks before beginning the study.
- •negative skin prick test for allergy
排除标准
- •had received acupuncture within the last four weeks before the start of the study
- •no history of diabetes mellitus, autonomic neuropathy, coronary heart disease or hypertension.
结局指标
主要结局
The change of subjective perception nasal ventilation
时间窗: at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture
The subjective perception of nasal ventilation was self-assessed by participants according to three categories: unchanged, better, and worse. Number of participants reported unchanged or better was analysed.
次要结局
- The change of exhaled nasal nitric oxide assessed by nitric oxide analyser(at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture)
- The change of nasal patency assessed by acoustic rhinometry(at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture)
- The change of substance P in nasal secretions were analysed by Enzyme linked immunosorbent assay(at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture)
- The change of nasal patency assessed by Rhinomanometer(at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture)
- The change of vasoactive intestinal peptide in nasal secretions were analysed by Enzyme linked immunosorbent assay(at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture)
- The change of neuropeptide Y in nasal secretions were analysed by Enzyme linked immunosorbent assay(at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture)
研究者
Luo Zhang
Director, Beijing Institute of Otolaryngology.
Beijing Tongren Hospital