Kinetic Oscillation Stimulation (KOS) in chronic hemodialysis: new potential anti-inflammatory treatment
| ISRCTN | ISRCTN49663124 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49663124 |
| Secondary identifying numbers | DIA-CAP version 1 |
- Submission date
- 26/11/2014
- Registration date
- 04/12/2014
- Last edited
- 04/12/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Many patients with end-stage renal (kidney)disease survive because of chronic dialysis. Dialysis does some of the work usually done by the kidneys, such as removing waste products and excess fluid, maintaining safe levels of potassium, sodium and bicarbonate in the blood stream and helping to control blood pressure. However dialysis patients have an increased risk of cardiovascular disease and therefore are at a high risk of premature death. This may be partly due to autonomic dysfunction, whereby the autonomic nervous system (which controls basic bodily functions such as heart rate, breathing rate, body temperature and so on) no longer works properly and chronic inflammation. We want to explore the effects of a non-invasive device 3-4 times weekly on inflammation in adult dialysis patients and potential changes in autonomic dysfunction over a period of 3 months.
Who can participate?
Adult patients undergoing chronic dialysis
What does the study involve?
Participants are treated with the Kinetic Oscillation Stimulation (KOS) device for 10-15 minutes, 3 times a week before their dialysis session. The device is inserted into a nostril with a probe which is then stimulated with a low electric current causing oscillations. The participant feels a vibrating sensation. We look for evidence of inflammation and assess variations in heart rate at the start and end of the study period.
What are the possible benefits and risks of participating?
Kinetic Oscillation Stimulation(KOS) is safe and has been used in over 100 patients with chronic rhinitis and migraine. The vibrating sensation is not painful but may cause a slight discomfort initially. If KOS does have an anti-inflammatory effect this may benefit the research subjects taking part in the study. However this cannot be guaranteed.
Where is the study run from?
Karolinska University Hospital (Sweden)
When is the study starting and how long is it expected to run for?
January 2014 to December 2016
Who is funding the study?
1. Stockholm County Council (ALF project) (Sweden)
2. Westman Foundation (Sweden)
3. Martin Rind Foundation (Sweden)
Who is the main contact?
Professor Annette Bruchfeld
Annette.bruchfled@ki.se
Contact information
Scientific
Dept of Renal Medicine, M99
Karolinska University Hospital
Stockholm
1186
Sweden
| Phone | +46-8-58580000 |
|---|---|
| annette.bruchfeld@ki.se |
Study information
| Study design | Interventional, single-centre, open-label study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Modulation of the Cholinergic Anti-inflammatory Pathway in DIAlysis |
| Study acronym | DIA-CAP |
| Study hypothesis | The overall aim of this open-label study is to investigate the effect of a new, non-pharmacological method that may induce changes in autonomic dysfunction in the dialysis setting and thereby influence chronic inflammation |
| Ethics approval(s) | Regional ethical review board, Stockholm, 23/04/2014, ref. 2014/538-31/1 |
| Condition | Chronic inflammation in chronic dialysis patients |
| Intervention | We will use the Kinetic Oscillation Stimulation (KOS) device in chronic hemodialysis 3 times weekly during 10-15 minutes prior to the dialysis session. The device is inserted into one of the nostrils with a probe which is then stimulated with a low electric current causing oscillations. The research subject experiences this as a vibrating sensation. Our hypothesis is that this may stimulate the cholinergic anti-inflammatory pathway via the vagus nerve and decrease inflammation in this patient group with underlying chronic inflammation. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 1. Inflammatory markers in serum and in stimulated whole blood during follow-up compared to prior to stimulation. 2. Heart rate variability by EKG ( autonomic dysfunction assessment) during follow-up compared to prior to stimulation |
| Secondary outcome measures | Health assessment questionnaires |
| Overall study start date | 01/01/2014 |
| Overall study end date | 31/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 10-12 |
| Participant inclusion criteria | All stable adult patients with no age limit undergoing chronic dialysis. |
| Participant exclusion criteria | Ongoing clinical infection. |
| Recruitment start date | 24/11/2014 |
| Recruitment end date | 31/12/2016 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Sweden
Sponsor information
Hospital/treatment centre
Dept of Renal Medicine, M99
Stockholm
14186
Sweden
"ROR" |
https://ror.org/00m8d6786 |
|---|
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Stockholm County Council
- Location
- Sweden
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We will as soon as possible present data from this study at conferences and as articles. However we are now in the early pilot stage and it is too early to present a time-line. |
| IPD sharing plan |
