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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027804

Enrollment

Registered

2017-07-01

Start date

2017-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

functional dyspepsia

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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)	—

Secondary

Measure	Time frame
<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)	—

Measure

Time frame

<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)

—

Countries

Japan

Contacts

Public ContactToshihisa Takeuchi

Osaka Medical College Hospigtal Endoscopy Center

in2097@osaka-med.ac.jp072-683-1221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026