臨床研究等提出・公開システム

Date of registration	Aug. 28, 2024
Last modified on	Aug. 28, 2024
Trial ID	jRCT1030240301

Scientific Title	A multicenter registry study on the enrollment and treatment progress of patients with dysfunctional breathing (A multicenter registry study on the enrollment and treatment progress of patients with dysfunctional breathing)
Public Title	dysfunctional breathing (dysfunctional breathing)

Contact for Scientific Queries	Name	Gon Yasuhiro
	Affiliation	Nihon University School of Medicine Itabashi Hospital
	Address	30-1 Ohyaguchi,kami-cho Itabashi-ku Tokyo
	Telephone	+81-3-3972-8111
	E-mail	gon.yasuhiro@nihon-u.ac.jp
Contact for Public Queries	Name	Gon Yasuhiro
	Affiliation	Nihon University School of Medicine Itabashi Hospital
	Address	30-1 Ohyaguchi,kami-cho Itabashi-ku Tokyo
	Telephone	+81-3-3972-8111
	E-mail	gon.yasuhiro@nihon-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Aug. 28, 2024
Target sample size		300
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Those who are between 18 and 90 years old at the time of obtaining consent. Those who have received a sufficient explanation of participation in this study, fully understood the study, and voluntarily provided written consent.
	Exclusion Criteria	Patients who meet the selection criteria but decline to participate in this study Patients who the principal investigator (at each facility) judges to be inappropriate as study subjects
	Age Minimum	18age old over
	Age Maximum	90age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Dysfunctional Breathing
Primary Outcome(s)		Based on the questionnaire scores, we will evaluate the impact on QOL and work productivity in DB patients.
Secondary Outcome(s)		Types and proportions of comorbidities in DB patients Relationship between Nijmegen scores of DB patients and various questionnaires and clinical indicators Phenotype classification of DB patients Outcomes of DB patients after 3 months (presence and type of drug therapy, psychological counseling, cognitive behavioral therapy, presence or absence of breathing training, presence or absence of improvement (GETE), referral destination, etc.)

Primary Sponsor	Nihon University School of Medicine Itabashi Hospital

Name of Certified Review Board	Nihon University School of Medicine, Itabashi Hospital, Clinical Research Review Committee
Address	30-1 Ohyaguchi,kami-cho Itabashi-ku, Tokyo
Telephone	+81-3-3972-8111
E-Mail	med.itabashi.clinicalresearch@nihon-u.ac.jp
Approval Status	Approval
Date of approval	May. 14, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none