![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000027804 |
Receipt No. | R000031860 |
Scientific Title | Analysis of the autonomic nerve function of patients with functional gastrointestinal disorder using a wearable device |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2020/12/21 |
Basic information | ||
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 |
|
Condition | ||
Condition | functional dyspepsia | |
Classification by specialty |
|
|
Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
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 |
Assessment | |
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) |
Base | |
Study type | Interventional |
Study design | |
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 |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Diagnosis | |
Type of intervention |
|
|
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 |
Eligibility | ||||
Age-lower limit |
|
|||
Age-upper limit |
|
|||
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 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
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 | ||||||
higuchi@osaka-med.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
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 | |||||||
in2097@osaka-med.ac.jp |
Sponsor | |
Institute | Osaka Medical College, Second Department of Internal Medicine |
Institute | |
Department |
Funding Source | |
Organization | Osaka Medical College, Second Department of Internal Medicine |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Osaka Medical College |
Address | 2-7 Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan |
Tel | 072-683-1221 |
rinri@osaka-med.ac.jp |
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 | 大阪医科大学附属病院 |
Other administrative information | |||||||
Date of disclosure of the study information |
|
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 | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
Date of protocol fixation |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031860 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |