Frailty SyndromeNCT07416708
The Impact of Transcutaneous Vagal Nerve Stimulation on Frailty Syndrome in Older Adults
A study testing Transcutaneous Auricular Vagus Nerve Stimulation and Physiotherapy in people with Frailty Syndrome and Dementia, run by Balnear and Rehabilitation Sanatorium Techirghiol at 1 site in Romania.
Trial summary
This clinical study, conducted at the Techirghiol Balneary and Rehabilitation Sanatorium, aims to evaluate the effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) in improving clinical and biological parameters associated with frailty in older adults. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Frailty Syndrome, Dementia
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation and Physiotherapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteRomania
- Study dates
- 1 Dec 2024to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years.
- Vertebro-peripheral osteoarthritic disease without contraindication for physiotherapy
- Patients with cognitive capacity to understand
Who cannot join
- History of major psychiatric disorders, under psychiatric medication or optimal treatment for associated symptoms.
- Long-term use of corticosteroid or nonsteroidal anti-inflammatory drugs up to one month before the study
- Sedative medication during hospitalization.
- Allergies or sensitivities to electrodes or the Nurosym device.
Trial locations and contacts
1 site in 1 country.
Romania1 site
Balneal and Rehabilitation Sanatorium Techirghiol
Techirghiol, Constanța County, 906100
About this study
Official title: Evaluation of the Transcutaneous Vagal Nerve Stimulation (Auricular Vagal Neuromodulation Therapy) on Cognitive Frailty, Sleep Quality, and Inflammation in Older Adults
This clinical study, conducted at the Techirghiol Balneary and Rehabilitation Sanatorium, aims to evaluate the effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) in improving clinical and biological parameters associated with frailty in older adults. Over a two-week period, participants aged over 60 years, without dementia, cardiac pacemakers, or auditory implants, will be assigned to two groups: an intervention group receiving active taVNS and a control group receiving sham stimulation. Both groups will undergo individualized medical rehabilitation therapies according to their clinical needs.
The study will assess frailty using the Edmonton Frailty Scale, sleep quality through the Pittsburgh Sleep Quality Index, and cognitive function with the Montreal Cognitive Assessment (MoCA) and the Rapid Cognitive Screen. Additionally, inflammatory markers (C-reactive protein, IL-6, TNF-alpha) will be measured at baseline and upon discharge.
The primary objective is to demonstrate that the intervention group will show greater improvements in cognitive scores, sleep quality, and reductions in inflammatory markers compared to the control group at the end of the study.
- Conditions
- Frailty Syndrome, Dementia
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation, Physiotherapy
- Medical subject headings
- Frailty, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve StimulationDevice
Also called Phisiotherapy
All patients received individual rehabilitation procedures tailored on their musculoskeletal degenerative disease.
PhysiotherapyProcedure or surgery
Physiotherapy is a non-invasive treatment used to relieve pain, improve mobility, and speed up recovery after injuries, surgeries, or chronic conditions. It helps restore body functions, improve posture, and prevent relapses.
| Study group | Role | What they receive |
|---|---|---|
| Aurical Vagus Nerve Stimulated Patients | Experimental | The patients received 1h per day auricular vagus nerve stimulation and individual rehabilitation procedures Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation; Procedure: Physiotherapy |
| Sham Group - Non stimulated patients | Sham comparator | These patients only received individual rehabilitation procedures Receives: Procedure: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the transcutaneous vagal nerve stimulation (Auricular Vagal Neuromodulation Therapy) on Cognitive Frailty
Investigation of AVNT effect on cognitive frailty using the Montreal Cognitive Assessment (MoCA-B), Edmonton Frailty Scale, and Rapid Cognitive Screen Test (RCS). Every one of the test is measured in units of a scale.
For Montreal Cognitive Assessment - Basic (MoCA-B) the total Score is 30 points. A score ≥ 26 is generally considered within normal limits Scores < 26 may suggest mild cognitive impairment (MCI). < 20 may suggest moderate cognitive impairment. In this study, we calculated both the total MoCA-B score and separate domain-specific scores to identify domain-level changes more precisely.
The Rapid Cognitive Test is a brief screening instrument used to detect mild cognitive impairment and early dementia. Maximum score:10 ; ≤5: Suggestive of dementia For the Edmonton Frail Scale (EFS), the scoring system is: Total score range: 0-17; Higher scores indicate greater frailty. It was administered only at baseline (upon admission) as a reference measure of frailty status.
Measured: From enrollment to the end of treatment at 10 days - MOCA-B and RCS test The Edmonton Frailty Scale was only used at admission as a reference measure of frailty status because meaningful changes in frailty status typically require longer time intervals.
Secondary outcomes (1)
Effects of AVNT (Trans-auricular vagus nerve stimulation) therapy on sleep quality
We used the Pittsburgh Sleep Quality Index (PSQI) to asses the quality of sleep.
Scoring - units per scale Total score range: 0-21 Score ≤ 5: Good sleep quality Score > 5: Poor sleep quality Higher scores indicate worse sleep quality. The PSQI evaluates 7 components: Subjective sleep quality, Sleep latency, Sleep duration, Habitual sleep efficiency, Sleep disturbances, Use of sleep medication, Daytime dysfunction.
In this study, both total PSQI score and component-level changes were analyzed.
Measured: We performed 2 measurements on day 1 and one on the final day (day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Dec 2024
- Primary completion1 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balnear and Rehabilitation Sanatorium Techirghiol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena-Valentina Ionescu, Balnear and Rehabilitation Sanatorium Techirghiol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416708
- Sponsor's protocol ID
- AmaliaVancea
- Status last verified
- Dec 2024
- First submitted
- 23 Jan 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Transcutaneous Vagal Nerve Stimulation (Auricular Vagal Neuromodulation Therapy) on Cognitive Frailty, Sleep Quality, and Inflammation in Older Adults
- ClinicalTrials.gov ID
- NCT07416708
- Acronym / sponsor ID
- AmaliaVancea
- Conditions
- Frailty Syndrome, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Balnear and Rehabilitation Sanatorium TechirghiolUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study, conducted at the Techirghiol Balneary and Rehabilitation Sanatorium, aims to evaluate the effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) in improving clinical and biological parameters associated with frailty in older adults. Over a two-week period, participants aged over 60 years, without dementia, cardiac pacemakers, or auditory implants, will be assigned to two groups: an intervention group receiving active taVNS and a control group receiving sham stimulation. Both groups will undergo individualized medical rehabilitation therapies according to their clinical needs.
The study will assess frailty using the Edmonton Frailty Scale, sleep quality through the Pittsburgh Sleep Quality Index, and cognitive function with the Montreal Cognitive Assessment (MoCA) and the Rapid Cognitive Screen. Additionally, inflammatory markers (C-reactive protein, IL-6, TNF-alpha) will be measured at baseline and upon discharge.
The primary objective is to demonstrate that the intervention group will show greater improvements in cognitive scores, sleep quality, and reductions in inflammatory markers compared to the control group at the end of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aurical Vagus Nerve Stimulated Patients | Experimental | Device: Transcutaneous Auricular Vagus Nerve Stimulation, Procedure: PhysiotherapyThe patients received 1h per day auricular vagus nerve stimulation and individual rehabilitation procedures |
| Sham Group - Non stimulated patients | Sham comparator | Procedure: PhysiotherapyThese patients only received individual rehabilitation procedures |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 60 years.
- Vertebro-peripheral osteoarthritic disease without contraindication for physiotherapy
- Patients with cognitive capacity to understand
Key exclusion criteria (4 listed)
- History of major psychiatric disorders, under psychiatric medication or optimal treatment for associated symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve StimulationAlso: PhisiotherapyAll patients received individual rehabilitation procedures tailored on their musculoskeletal degenerative disease. | Device | Aurical Vagus Nerve Stimulated Patients |
| PhysiotherapyPhysiotherapy is a non-invasive treatment used to relieve pain, improve mobility, and speed up recovery after injuries, surgeries, or chronic conditions. It helps restore body functions, improve posture, and prevent relapses. | Procedure or surgery | Aurical Vagus Nerve Stimulated Patients, Sham Group - Non stimulated patients |
Primary outcome
Evaluation of the transcutaneous vagal nerve stimulation (Auricular Vagal Neuromodulation Therapy) on Cognitive Frailty
Time frame: From enrollment to the end of treatment at 10 days - MOCA-B and RCS test The Edmonton Frailty Scale was only used at admission as a reference measure of frailty status because meaningful changes in frailty status typically require longer time intervals.
Investigation of AVNT effect on cognitive frailty using the Montreal Cognitive Assessment (MoCA-B), Edmonton Frailty Scale, and Rapid Cognitive Screen Test (RCS). Every one of the test is measured in units of a scale. For Montreal Cognitive Assessment - Basic (MoCA-B) the total Score is 30 points. A score ≥ 26 is generally considered within normal limits Scores < 26 may suggest mild cognitive impairment (MCI). < 20 may suggest moderate cognitive impairment. In this study, we calculated both the total MoCA-B score and separate domain-specific scores to identify domain-level changes more precisely. The Rapid Cognitive Test is a brief screening instrument used to detect mild cognitive impairment and early dementia. Maximum score:10 ; ≤5: Suggestive of dementia For the Edmonton Frail Scale (EFS), the scoring system is: Total score range: 0-17; Higher scores indicate greater frailty. It was administered only at baseline (upon admission) as a reference measure of frailty status.
1 secondary outcome
Effects of AVNT (Trans-auricular vagus nerve stimulation) therapy on sleep quality
Time frame: We performed 2 measurements on day 1 and one on the final day (day 10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagus Nerve Stimulation and Physiotherapy in people with Frailty Syndrome and Dementia, run by Balnear and Rehabilitation Sanatorium Techirghiol at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the transcutaneous vagal nerve stimulation (Auricular Vagal Neuromodulation Therapy) on Cognitive Frailty (time frame: From enrollment to the end of treatment at 10 days - MOCA-B and RCS test The Edmonton Frailty Scale was only used at admission as a reference measure of frailty status because meaningful changes in frailty status typically require longer time intervals.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.