臨床研究等提出・公開システム

Scientific Title	A study on clinical effectiveness of acoustic energy visualization in rehabilitation of voice disorders
Public Title	A study on clinical effectiveness of acoustic energy visualization in rehabilitation of voice disorders

Contact for Scientific Queries	Name	Kawamura Naoko
	Affiliation	Himeji Dokkyo University
	Address	7-2-1 Kamiohno, Himeji, Hyogo
	Telephone	+81-772239020
	E-mail	kawamura@gm.himeji-du.ac.jp
Contact for Public Queries	Name	Kawamura Naoko
	Affiliation	Himeji Dokkyo University
	Address	7-2-1 Kamiohno, Himeji, Hyogo
	Telephone	+81-772239020
	E-mail	kawamura@gm.himeji-du.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Aug. 22, 2023
Actual date of first enrollment
Target sample size		22
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with voice disorders visiting the Department of Otorhinolaryngology, Kobe City Medical Center General Hospital, who will undergo tube phonation training.
	Exclusion Criteria	Patients with hearing impairment Patients with motor/sensory disorders
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender
Health Condition(s) or Problem(s) Studied		Voice disorders
Intervention(s)		In this study, the vocalization training support systems developed in the previous study will be introduced into the rehabilitation of voice disorders. In addition to the usual tube phonation training, tube phonation training using the proposed system will be conducted and its clinical effectiveness will be verified.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Acoustic analysis
Secondary Outcome(s)		Acoustic analysis, Vocal function, voice quality, user evaluation questionnaire

Primary Sponsor	none

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Kobe city hospital organization certified review board
Address	none, Hyogo
Telephone	+81-78-302-5176
E-Mail	c_crb@kcho.jp
Approval Status	Approval
Date of approval	May. 08, 2023

Name of Certified Review Board	Himeji Dokkyo University, Bioethics Committee
Address	none, Hyogo
Telephone	+81-77-223-2211
E-Mail	soumu@himeji-du.ac.jp
Approval Status	Approval
Date of approval	May. 08, 2023

Plan to share IPD
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Jan. 14, 2025	(this page)	Changes
1	Aug. 22, 2023	Detail

List of change history