Elucidation of the mechanism of action of Epipharyngeal Abrasive Therapy

JRCT ID: jRCT1011240030

Registered date:23/08/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy(Analysis of inflammatory diseases expected to regulate inflammation)
• Date of first enrollment: 23/08/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Nasal swabs and laryngeal crimpers are used for nasopharyngeal abrasion: a nasal swab coated with 0.5-1% zinc chloride solution is inserted through either nostril to reach the nasopharynx, and then abrasion is performed. A laryngeal wound swab is then inserted through the oral cavity and rubbed on the posterior wall of the pharynx and nasopharynx. The procedure is terminated after visually checking for bleeding.

Outcome(s)

• Primary Outcome: Comparison of the degree of T cell activation by anti-CD3/CD28 antibodies before and after nasopharyngeal abrasion

Secondary Outcome

1. Comparison of the activation state of immune cells in patients treated with nasopharyngeal abrasion therapy with previously reported data
2. Comparison of positive expression and intensity of expression of molecules induced by nasopharyngeal abrasion therapy in patients with inflammatory diseases
3. Comparison of disease-associated gene variants with those previously reported in patients with disease
4. Correlation between brain activity data in MRI and expression of various analyzed molecules
5. Correlation between Allergy, Sleep, and Stress Questionnaire Score and the degree of T cell activation before and after nasopharyngeal abrasion

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable

Include criteria

1) Eligible persons are considered eligible if they meet all of the (2) selection criteria and none of the (3) exclusion criteria.
(1) Eligible persons
Healthy volunteers.
The term "healthy" is defined as "not currently hospitalized with a chronic inflammatory disease.

(2) Selection criteria
(1) Age 18 years or older at the time of consent.
(2) Those who understand the purpose of the study and have given their free and voluntary written consent to participate in the study.

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Exclude criteria

Persons who fall under any one of the following categories shall be excluded from eligibility.
(i) Those who have had acute heart failure, myocardial infarction, or pulmonary edema within the past 3 months.
(ii) Patients with a history of cerebral or central nervous system lesions
(iii) Patients receiving concomitant vagus nerve stimulation therapy
(iv) Patients with a history of epilepsy
(5) Patients with a history of severe cardiovascular disease
(vi) Patients with pneumothorax
(vii) Patients with uncontrolled infection
(viii) Pregnant or lactating
(viii) Pregnant or lactating mothers (ix) Patients with skin hypersensitivity and a history of skin symptoms caused by metal or other substances
(10) Those who have difficulty in oral intake
(11) Patients with severe renal dysfunction (estimated glomerular filtration rate (eGFR) less than 30 mL/min)
(12) Patients with tumor lesions in the head and neck region that obstruct the nasal cavity or oral cavity.
Patients with a cardiac pacemaker or an implantable cardioverter-defibrillator
(iv) Persons who are ineligible to participate in the study on the attached "MRI Questionnaire" (see Appendix MRI Questionnaire).
(xv) Other subjects who are deemed inappropriate as research subjects by the principal investigator or subinvestigator.

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Related Information

• Primary Sponsor: Konnno Satoshi