UMIN-CTR Clinical Trial

Basic information
Public title	Establishment of autonomic function tests reflecting stress induced by acute inflammatory diseases in otolaryngology
Acronym	Establishment of autonomic function tests reflecting stress induced by acute inflammatory diseases in otolaryngology
Scientific Title	Establishment of autonomic function tests reflecting stress induced by acute inflammatory diseases in otolaryngology
Scientific Title:Acronym	Establishment of autonomic function tests reflecting stress induced by acute inflammatory diseases in otolaryngology
Region	Japan

Condition
Condition	Acute inflammatory diseases in otolaryngology- heard and neck surgery required treatments
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate parameters and conditions of pupil light reflex and heart rate variability reflecting stress reaction induced by acute inflammatory diseases
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Parameters of Pupil light reflex (PLR) and Heart rate variability (HRV) at two times before tonsillectomy and POD1, 2 and 2-4 weeks. Pupil: initial diameter, minimum diameter, latency, max constriction velocity, averaged constriction velocity, constriction ratio, averaged dilation velocity, 4 different stimulus intensity (10,50,121,180) HRV: LF norm, HF norm, LF/HF
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
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Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	10 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with acute inflammatory diseases required hospitalization treatment in ENT field
Key exclusion criteria	1) Patients with severe central neural disorders and cardiac disorders. 2) Patients whom doctors judge as an inappropriate.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name MASAAKI ISHIKAWA
Organization	Hyogo Prefectural Amagasaki General Medical Center
Division name	Department of otolaryngology and head and neck
Zip code
Address	Hyogo prefecture amagasaki city higashinannbacho 2 17-77
TEL	06-6480-7000
Email	m_ishikawa@ent.kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name MASAAKI ISHIKAWA
Organization	Hyogo Prefectural Amagasaki General Medical Center
Division name	Department of otolaryngology and head and neck
Zip code
Address	Hyogo prefecture amagasaki city higashinannbacho 2 17-77
TEL	06-6480-7000
Homepage URL
Email	m_ishikawa@ent.kuhp.kyoto-u.ac.jp

Sponsor
Institute	Hyogo Prefectural Amagasaki General Medical Center
Institute
Department

Funding Source
Organization	Shiono wellness foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 04 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
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Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 07 Month 31 Day
Date of IRB	2018 Year 08 Month 02 Day
Anticipated trial start date	2018 Year 08 Month 09 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Observational study(Prospective cohort study) To explore the parameters obtained from pupil light reflex and heart rate variability for reflecting the extent of the phycological and psychological burden due to inflammatory diseases. Subjective evaluation: Numerical rating scale for pain intensity, POMS and STAI for mood alteration Objective evaluation: Heart rate variability and pupil light reflex(4 different stimulus intensities) 4 assessment points: 1. before treatment 2. day1 3. day2 4. 1-4 week Confounding factors: POMS, STAI, NRS, age, sex, BMI, social life such as smoking and drinking, menstrual status, surgical procedure type, stimulus intensities of pupil light reflex

Management information
Registered date	2019 Year 03 Month 03 Day
Last modified on	2020 Year 09 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041088