UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061881 |
|---|---|
| Receipt number | R000070806 |
| Scientific Title | A Prospective Exploratory Study of Autonomic Regulation Induced by Paced Slow Breathing (6 Breaths per Minute) in Patients with Diabetic Autonomic Neuropathy |
| Date of disclosure of the study information | 2026/06/11 |
| Last modified on | 2026/06/11 19:05:57 |
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Basic information
Public title
A Prospective Exploratory Study of Autonomic Biofeedback in Patients with Diabetic Autonomic Neuropathy
Acronym
A Prospective Exploratory Study of Autonomic Biofeedback in Patients with Diabetic Autonomic Neuropathy
Scientific Title
A Prospective Exploratory Study of Autonomic Regulation Induced by Paced Slow Breathing (6 Breaths per Minute) in Patients with Diabetic Autonomic Neuropathy
Scientific Title:Acronym
PSB-DAN Study
Region
| Japan |
Condition
Condition
Patients with Diabetic Autonomic Neuropathy (
Classification by specialty
| Medicine in general | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
To exploratorily evaluate the acute effects and the effects after one week of training on RMSSD (root mean square of successive differences).
To evaluate changes in autonomic symptom scores measured by the Composite Autonomic Symptom Score 31 (COMPASS-31).
To investigate the association between changes in RMSSD and changes in COMPASS-31 scores.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Change in COMPASS-31 score from baseline to the end of the intervention
Key secondary outcomes
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)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ikuko |
| Middle name | |
| Last name | Ito |
Organization
Shimane University Hospital
Division name
Rehabilitation Department
Zip code
693-8501
Address
89-1 Enya-cho, Izumo City, Shimane Prefecture
TEL
0853202457
simada@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Ikuko |
| Middle name | |
| Last name | Ito |
Organization
Shimane University Hospital
Division name
Rehabilitation Department
Zip code
6938501
Address
89-1 Enya-cho, Izumo City, Shimane Prefecture
TEL
0853202457
Homepage URL
simada@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Ikuko Ito
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shimane University Hospital
Address
89-1 Enya-cho, Izumo City, Shimane Prefecture
Tel
0853-20-2457
simada@med.shimane-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
島根県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 11 | Day |
Last modified on
| 2026 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070806
