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A Prospective Exploratory Study of Autonomic Biofeedback in Patients with Diabetic Autonomic Neuropathy

A Prospective Exploratory Study of Autonomic Regulation Induced by Paced Slow Breathing (6 Breaths per Minute) in Patients with Diabetic Autonomic Neuropathy - PSB-DAN Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061881
Enrollment
10
Registered
2026-06-11
Start date
2026-06-15
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

Patients with Diabetic Autonomic Neuropathy (

Interventions

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 st

Sponsors

Shimane University
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
Change in COMPASS-31 score from baseline to the end of the intervention

Secondary

MeasureTime 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

Public ContactIkuko Ito

Shimane University Hospital Rehabilitation Department

simada@med.shimane-u.ac.jp0853202457

Outcome results

None listed

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