Tokyo, June 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061881) titled 'A Prospective Exploratory Study of Autonomic Biofeedback in Patients with Diabetic Autonomic Neuropathy' on June 11.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Shimane University

Condition: Condition - Patients with Diabetic Autonomic Neuropathy ( Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the safety and feasibility of a breathing training program using slow and deep breathing (6 breaths per minute) in patients with diabetic autonomic neuropathy. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Participants will perform slow, deep breathing exercises at a pace of 6 breaths per minute. The intervention period will be one week, with participants receiving guidance from research staff at the start of the intervention. Thereafter, they will continue the exercises daily on their own. Heart rate variability and autonomic nervous system symptoms will be evaluated before and after the intervention.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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. Key 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. Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 15 Day Anticipated trial start date - 2026 Year 06 Month 15 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070806

Disclaimer: Curated by HT Syndication.