Patients with Diabetic Autonomic Neuropathy (
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants aged 18 years or older at the time of informed consent. 2. Participants diagnosed with diabetic autonomic neuropathy by a physician. 3. Participants with autonomic symptoms who are judged by the attending physician to be suspected of having autonomic neuropathy and who provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Participants with severe cardiac disease (including arrhythmias). 2. Participants with an implanted pacemaker. 3. Participants judged to be medically unsuitable for the breathing intervention. 4. Participants who, in the judgment of the principal investigator, are unable to understand the study procedures, learn the breathing technique, or perform self-administered breathing training for one week due to cognitive impairment or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in COMPASS-31 score from baseline to the end of the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in heart rate variability indices (RMSSD, HF, and CVRR) Change in RR interval Occurrence of adverse events Adherence to the breathing regulation intervention (compliance rate) | — |
Countries
Japan
Contacts
Shimane University Hospital Rehabilitation Department