UMIN-CTR Clinical Trial

Public title

Analysis of the autonomic nerve function of patients with functional gastrointestinal disorder using a wearable device

Acronym

Analysis of the autonomic nerve function of patients with functional gastrointestinal disorder using a wearable device

Scientific Title

Analysis of the autonomic nerve function of patients with functional gastrointestinal disorder using a wearable device

Scientific Title:Acronym

Analysis of the autonomic nerve function of patients with functional gastrointestinal disorder using a wearable device

Region

Japan

Condition

functional dyspepsia

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To clarify the pathophysiology by serially analyzing the association between gastrointestinal symptoms and changes in the autonomic nerve function using a wearable device.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Rate of change in the autonomic nerve function at the time of symptom appearance (maximum rate of change in HF-LF/HF from the baseline)

Key secondary outcomes

<Autonomic nerve function>
1. Mean HF-LF/HF during 24 hours, total power (VLF+LF+HF)
2. Mean HF-LF/HF at the baseline
3. Mean HF-LF/HF at the time of symptom appearance
4. Mean HF-LF/HF before defecation to on defecation, maximum/minimum HF-LF/HF
5. Mean HF-LF/HF after defecation, maximum/minimum HF-LF/HF
6. Rate of change in HF-LF/HF before and after defecation
7. Symptom index (SI)
*SI = Number of symptoms with autonomic balance abnormalities during 24 hours/total number of symptoms that appeared during 24 hours
8. Symptom sensitivity index (SSI)
*SSI = Number of symptoms with autonomic balance abnormalities during 24 hours/total number of autonomic balance abnormalities during 24 hours
9. Mean HF-LF/HF during sleep
10. Mean HF-LF/HF on awakening
<Gait, posture, and sleep>
The association between gait/posture and gastrointestinal symptoms will be examined by analyzing bio-information, and the quality of sleep will be compared between groups.
<Background factors>
1. Age, sex, body mass index (BMI)
2. Smoking, alcohol consumption
3. Presence or absence of oral drugs (acid secretion inhibitors, digestive motor function-improving drugs, 5-HT3 receptor antagonists, mucosal epithelial function-changing drugs, purgatives, antidiarrheals, Chinese herbal drugs, antidepressants, anxiolytic drugs, anticholinergic drugs)
4. Total duration of gastrointestinal symptom appearance, severity of symptoms, frequency of symptoms
5. Anxiety/depressive factors
6. Health-related quality of life (HR-QOL)

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Patient group in which patients with functional dyspepsia are instructed to wear a wearable device for 1 day

Interventions/Control_2

Control group in which healthy adults are instructed to wear a wearable device for 1 day

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

A. Patients with functional gastrointestinal disorder (functional dyspepsia, irritable bowel syndrome)
-Patients with functional gastrointestinal disorder meeting the Rome IV diagnostic criteria
-Patients aged 20 to 79 years
B. Healthy adults
-Adults without gastrointestinal symptoms
-Those aged 20 to 79 years

Key exclusion criteria

Those with a history of gastrointestinal surgery
-Pacemaker- or implantation-type defibrillator-wearing adults
-Those who are considered ineligible by the investigator

Target sample size

60

Name of lead principal investigator

1st name	Kazuhide
Middle name
Last name	Higuchi

Organization

Osaka Medical College

Division name

Second Department of Internal Medicine

Zip code

569-8686

Address

2-7 Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan

TEL

072-683-1221

Email

higuchi@osaka-med.ac.jp

Name of contact person

1st name	Toshihisa
Middle name
Last name	Takeuchi

Organization

Osaka Medical College Hospigtal

Division name

Endoscopy Center

Zip code

569-8686

Address

2-7 Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan

TEL

072-683-1221

Homepage URL

Email

in2097@osaka-med.ac.jp

Institute

Osaka Medical College, Second Department of Internal Medicine

Institute

Department

Personal name

Organization

Osaka Medical College, Second Department of Internal Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Osaka Medical College

Address

2-7 Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan

Tel

072-683-1221

Email

rinri@osaka-med.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪医科大学附属病院

Date of disclosure of the study information

2017

Year

07

Month

01

Day

URL releasing protocol

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0278922

Publication of results

Published

URL related to results and publications

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0278922

Number of participants that the trial has enrolled

20

Results

In patients with IBS, sympathetic nerve activity was activated 2 min before defecation, which was correlated with abdominal symptoms and lower QOL.

Results date posted

2022

Year

12

Month

23

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

This was a prospective multicenter study in which patients with IBS visiting Osaka City University and Osaka Medical and Pharmaceutical University participated between July 2018 and May 2019. All patients with IBS met the Rome IV criteria and had received a medical diagnosis of IBS prior to the study. In the control group, sex- and age-matched subjects were recruited via the Internet; they did not have gastrointestinal symptoms and did not meet the Rome IV criteria for IBS and functional dyspepsia. Participants in both groups were excluded if they had a history of gastrointestinal surgery or used a pacemaker or an implantable cardioverter defibrillator. We compared the data obtained between patients with IBS and controls. The study protocol was approved by the Ethics Committee of the Osaka City University Graduate School of Medicine (No. 3686; approved on January 25, 2017). Written informed consent was obtained from all of the participants in this study. If consent was waived, patients were not included in the study.

Participant flow

HRV was recorded using a Hitoe1 (TORAY Industries, Inc., Tokyo, Japan; NTT DOCOMO, Inc., Tokyo, Japan), which is a wearable T-shirt device, to monitor the 24-h HRV every 40 milisecond (ms). This device has been used as a tool for measuring ANS activity in sports medicine and post-stroke patients, and its validity has been demonstrated [16, 17]. Simultaneously, life events, such as the timing of the appearance or disappearance of abdominal symptoms, defecation, eating, and awakening or sleep, were recorded in real time using a smartphone application software during HRV recording. This software was newly developed in a joint effort by NTT DATA KANSAI Corporation, NTT DATA MSE Corporation, Osaka City University, and Osaka Medical and Pharmaceutical University and is not sold in the open market. The participants conducted normal daily activities until the 24-h period was over.In addition, all participants were asked to complete questionnaires including the IBS severity scoring system (IBS-SSS) , the gastrointestinal symptom rating scale (GSRS) , the Hospital Anxiety and Depression Scale (HADS), and the Japanese version of the 8-item Short-Form Health Survey (SF-8) prior to measuring ANS activity. The SF-8 measures health-related quality of life (QOL) based on scores from eight domains and two summaries, including physical functioning, physical role, bodily pain, general health perception, vitality, social functioning, emotional role, mental health, and physical and mental component summaries, with lower scores reflecting a worse QOL.

Adverse events

none

Outcome measures

Alerts do not allow completion of the input.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2017

Year

07

Month

01

Day

Date of IRB

2017

Year

05

Month

08

Day

Anticipated trial start date

2017

Year

07

Month

01

Day

Last follow-up date

2020

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

06

Month

18

Day

Last modified on

2022

Year

12

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031860