Clinical trial NCT02603588: The Effects of Sphenopalatine Ganglion Acupuncture on Nasal Function
Official title: Effects of Sphenopalatine Ganglion Acupuncture on Nasal Ventilation and Autonomic Nervous Activity in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Acupuncture
Sphenopalatine ganglion
Nasal ventilation
Neuropeptides
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The change of subjective perception nasal ventilation
timeFrame: at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture
Secondary outcomes:
measure: The change of exhaled nasal nitric oxide assessed by nitric oxide analyser
timeFrame: at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture
measure: The change of nasal patency assessed by acoustic rhinometry
timeFrame: at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture
measure: The change of substance P in nasal secretions were analysed by Enzyme linked immunosorbent assay
timeFrame: at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture
measure: The change of nasal patency assessed by Rhinomanometer
timeFrame: at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture
measure: The change of vasoactive intestinal peptide in nasal secretions were analysed by Enzyme linked immunosorbent assay
timeFrame: at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture
measure: The change of neuropeptide Y in nasal secretions were analysed by Enzyme linked immunosorbent assay
timeFrame: at baseline, 30 minutes, 2 hours, and 24 hours after acupuncture
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
affiliation: Beijing Institute of Otolaryngology
name: Luo Zhang
role: PRINCIPAL_INVESTIGATOR
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