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A Study to See Whether Gentle Ear Nerve Stimulation and Slow Breathing Can Improve Heart Function and Daily well-being and Blood Sugar Control in People with Diabetes.

Investigating the effect of transcutaneous vagus nerve stimulatioin and box breathing on autonomic regulation, quality of life and glucose regulation in individuals with cardiac autonomic neuropathy: A randomised controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/103951
Enrollment
60
Registered
2026-02-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications

Interventions

Intervention1: Group 1 Sham transcutaneous vagus nerve stimulation and Box Breathing and patient education: The intervention in group 1 is given for a duration of 15 min, 2 times a day for 2 week. Con

Sponsors

Anshu
Lead Sponsor
Parasym Ltd
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: verified diagnosis of type 2 diabetes mellitus diagnosed using ADA diagnostic criteria. CAN diagnosed using COMPASS- 31 score more than 16. Ewing battery score equal to 1 or more than 1 abnormal test.

Exclusion criteria

Exclusion criteria: history of coronary artery disease, renal disease or cerebrovascular disease. BP less than 100 by 60 or more than 160 by 105. Previous surgery of vagus nerve. Patient who had any implant near chest, face or neck region.

Design outcomes

Primary

MeasureTime frame
Autonomic regulation Glucose regulation Quality of lifeTimepoint: Baseline, 2 weeks and 4 weeks—

Secondary

MeasureTime frame
nilTimepoint: nil—

Countries

India

Contacts

Public ContactAnshu

SGT University

aditi_fphy@sgtuniversity.org9650878448

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026