Effects of repeated aural stimulation on substance P concentration in blood, saliva and sputum and swallowing function in healthy subjects and patients with dysphagia: a phase 1-2 study

JRCT ID: jRCTs061180080

Registered date:20/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Dysphasia
• Date of first enrollment: 25/02/2013
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Repeated aural stimulation with capsaicin ointment

Outcome(s)

Primary Outcome

Healthy subjects
Substance P concentration in blood, saliva and sputum
Patients with dysphagia
Substance P concentration in blood, saliva and sputum and swallowing function

• Secondary Outcome: Adverse reaction such as otalgia or abnormality of eardrum or ear canal

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 100age old
• Gender: Both

Include criteria

Healthy subjects
1) Male and female between the age of 20 and 65 years
2) Healthy subjects without dysphagia
Patients with dysphagia
1) Male and female between the age of 20 and 100 years
2) Patients with dysphagia

Exclude criteria

Healthy subjects
1) Subjects who was excluded by investigators
Patients with dysphagia
1) Patients with serious complications
2) Patients who was excluded by investigators

Related Information

• Primary Sponsor: Kitamura Yoshiaki