A New Phototubometry

JRCT ID: jRCTs062190003

Registered date:29/05/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: External and middle ear diseases
• Date of first enrollment: 09/11/2022
• Target sample size: 80
• Study type: Interventional
• Intervention(s): In the external and middle ear diseases group, Phototubometry is performed simultaneously with Sonotubometry for normal examination. In the control group, Phototubometry and Sonotubometry are performed on the day of consent acquisition or on the day of adjustment at a late day, then safety is evaluated in the one week follow-up period.

Outcome(s)

• Primary Outcome: Evaluation of the results of a Phototubometry System for the external and middle ear diseases (e.g. patulous Eustachian tube, otitis media with effusion, adhesive otitis media, cholesteatoma, external auditory canal stenosis, tympanosclerosis, otosclerosis, perilymph fistula, cholesterin granuloma, etc.).

Secondary Outcome

Safety including adverse events and Side Effects through examination.
During the Sonotubometry and Phototubometry, Changes in the Eustachian tube function are examined while adding external factors (e.g. rest position, swallowing, breath-holding, vowel production,).
Relevance between the sence of resistance at the Eustachian tube and the results of Sonotubometry and Phototubometry,

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

Ear disease group:
1) Male and female aged 20 to 80 years old at the time of acquisition.
2) Patients have the external or middle ear disease (chronic otitis media, otitis media with effusion, adhesive otitis media, cholesteatoma, ear canal stenosis, tympanic sclerosis, otosclerosis, perilymph fistulas, cholesterin granuloma, etc.) or suspected the Eustachian tube dysfunction indicated by diagnostic criteria.
3) Patients require the Eustachian tube dysfunction test by sonotubometry.
4) Patients got consent from himself / herself.
Control group:
1) Male and female aged 20 to 80 years old at the time of acquisition.
2) There is no ear / sinus disease before, no one has subjective symptoms related to ears.
3) Persons do not have subjective symptoms, no abnormality was found at physical examination, and were judged healthy by the reseach director.
4) Persons got consent from himself / herself.

Exclude criteria

Ear disease group:
1) Patients have been treated for the Eustachian tube dysfunction with Eustachian tube massager, nose drops, or Eustachian tube obstruction procedure.
2) Lidocaine allergy
3) There are malformations and diseases in the nasal cavity or nasopharynx
4) Patients were judged inappropriate by the research director.

Control group;
1) Persons have been treated for the Eustachian tube dysfunction with Eustachian tube massager, nose drops, or Eustachian tube obstruction procedure.
2) Lidocaine allergy
3) There are malformations and diseases in the nasal cavity or nasopharynx
4) Persons were judged inappropriate by the research director.

Related Information

• Primary Sponsor: Yazama Hiroaki