Arousal, ConfusionalNCT06549205
Effects of Trigeminal Neurostimulation on Heart Rate Variability: Comparing Tragus and Tongue Stimulation.
A study testing device that stimulates the dorsal surface of the tongue and device that stimulates the tragus in people with Arousal, Confusional, run by University of L'Aquila at 1 site in Italy.
Trial summary
this study wants to analyse the effect of trigeminal stimulation on Heart rate Variability. There are going to be two groups, in the test group it will be administered stimulation of the tongue with TENS, while in the control goup TENS will be administered at tragus level. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Arousal, Confusional
- What is being tested?
- device that stimulates the dorsal surface of the tongue and device that stimulates the tragus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 2 Apr 2022to 12 Jan 2024
- 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 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Women
- Age 18-30 years
Who cannot join
- presence of acute and/or chronic cardio-circulatory and respiratory disorders
- metabolic and autonomic system disorders
- intake of excitatory or inhibiting substances of the peripheral and central nervous system
- presence of generalised anxiety and/or panic attacks or mood disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Trigeminal Neurostimulation on Heart Rate Variability: Comparing Cutaneous (Tragus) and Tongue (Antero-Dorsal Mucosa) Stimulation.
this study wants to analyse the effect of trigeminal stimulation on Heart rate Variability. There are going to be two groups, in the test group it will be administered stimulation of the tongue with TENS, while in the control goup TENS will be administered at tragus level.
Read the detailed description
This study analyses the effect of trigeminal stimulation with TENS on Heart rate variability (HRV). A new intraoral device will be administered on the dorsal surface of the tongue for TENS stimulation in the test group. The RMSSD, LF, HF and LF/HF will be monitered by photoplethysmographic wave. the results obtained with tongue stimulation will be compared with the results obtained in the control group, where it will be administered TENS stimulation at the tragus level. This work sought to assess whether there is a difference in HRV in relation to the site of application of dental ULFTENS (tragus vs tongue).
If effective in reducing the activity of arousal circuits, this tongue-level stimulation technique could have new clinical applications.
- Conditions
- Arousal, Confusional
- Being tested
- device that stimulates the dorsal surface of the tongue, device that stimulates the tragus
- Keywords
- Trigeminal electrical stimulation, ULFTENS, Heart rate variability, tragus, tongue
- Medical subject headings
- Sleep Arousal Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
device that stimulates the dorsal surface of the tongueDevice
the device will be placed on the dorsal surface of the tongue. this instrument has two electrodes in turn connected to the TENS, so ultra low frequency stimulation (<0.66 Hz) will be administered
device that stimulates the tragusDevice
two electrodes will be placed at tragus level for the administration of dental ULFTENS
| Study group | Role | What they receive |
|---|---|---|
| TUD group | Experimental | an intraoral device will be administered in the TUD group in order to provide the stimulation of the dorsal surface of the tongue with dental TENS. The trial will last approximately 24 minutes, after the first 6 minutes, TENS activation will take place and how HRV values change will be evaluated. The Heart rate Variability parameters will be analysed with photopletismographic wave after 6 minutes of tongue stimulation Receives: Device: device that stimulates the dorsal surface of the tongue |
| Tragus group | Active comparator | patients in this group will be administered traditional trigeminal stimulation with dental TENS at tragus level. Tens will be turned on for 6 minutes in which the HRV parameters will be analyzed with the photoplethysmograph and compared with the data obtained in the TUD group. Receives: Device: device that stimulates the tragus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on Low Frequency parameter (LF)
Whether or not HRV parameter (LF) improve following tongue and tragus stimulation will be assessed by photopletismographic wave
Measured: 12 minutes
Changes on Root mean square standard deviation (RMSSD) parameter
Whether or not HRV parameter (RMSSD) improve following tongue and tragus stimulation will be assessed by photopletismographic wave
Measured: 12 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start2 Apr 2022
- Primary completion24 Jun 2023
- Study completion12 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arousal, ConfusionalStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Di Nicolantonio, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549205
- Sponsor's protocol ID
- 16137/2016
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Monaco A, Cattaneo R, Di Nicolantonio S, Strada M, Pietropaoli D, Ortu E. Effects of trigeminal neurostimulation on heart rate variability: comparing cutaneous (Tragus) and tongue (Antero-Dorsal mucosa) stimulation. BMC Oral Health. 2024 Oct 20;24(1):1257. doi: 10.1186/s12903-024-04914-2.
PubMed 39428464
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Trigeminal Neurostimulation on Heart Rate Variability: Comparing Cutaneous (Tragus) and Tongue (Antero-Dorsal Mucosa) Stimulation.
- ClinicalTrials.gov ID
- NCT06549205
- Acronym / sponsor ID
- 16137/2016
- Conditions
- Arousal, Confusional
- Keywords
- Trigeminal electrical stimulation, ULFTENS, Heart rate variability, tragus, tongue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Study start
- 2 Apr 2022 (actual)
- Primary completion
- 24 Jun 2023 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 12 Aug 2024 (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 study wants to analyse the effect of trigeminal stimulation on Heart rate Variability. There are going to be two groups, in the test group it will be administered stimulation of the tongue with TENS, while in the control goup TENS will be administered at tragus level.
Detailed description
This study analyses the effect of trigeminal stimulation with TENS on Heart rate variability (HRV). A new intraoral device will be administered on the dorsal surface of the tongue for TENS stimulation in the test group. The RMSSD, LF, HF and LF/HF will be monitered by photoplethysmographic wave. the results obtained with tongue stimulation will be compared with the results obtained in the control group, where it will be administered TENS stimulation at the tragus level. This work sought to assess whether there is a difference in HRV in relation to the site of application of dental ULFTENS (tragus vs tongue).
If effective in reducing the activity of arousal circuits, this tongue-level stimulation technique could have new clinical applications.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TUD group | Experimental | Device: device that stimulates the dorsal surface of the tonguean intraoral device will be administered in the TUD group in order to provide the stimulation of the dorsal surface of the tongue with dental TENS. The trial will last approximately 24 minutes, after the first 6 minutes, TENS activation will take place and how HRV values change will be evaluated. The Heart rate Variability parameters will be analysed with photopletismographic wave after 6 minutes of tongue stimulation |
| Tragus group | Active comparator | Device: device that stimulates the traguspatients in this group will be administered traditional trigeminal stimulation with dental TENS at tragus level. Tens will be turned on for 6 minutes in which the HRV parameters will be analyzed with the photoplethysmograph and compared with the data obtained in the TUD group. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Women
- Age 18-30 years
Key exclusion criteria (4 listed)
- presence of acute and/or chronic cardio-circulatory and respiratory disorders
- metabolic and autonomic system disorders
- intake of excitatory or inhibiting substances of the peripheral and central nervous system
- presence of generalised anxiety and/or panic attacks or mood disorders.
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 |
|---|---|---|
| device that stimulates the dorsal surface of the tonguethe device will be placed on the dorsal surface of the tongue. this instrument has two electrodes in turn connected to the TENS, so ultra low frequency stimulation (<0.66 Hz) will be administered | Device | TUD group |
| device that stimulates the tragustwo electrodes will be placed at tragus level for the administration of dental ULFTENS | Device | Tragus group |
Primary outcome
Changes on Low Frequency parameter (LF)
Time frame: 12 minutes
Whether or not HRV parameter (LF) improve following tongue and tragus stimulation will be assessed by photopletismographic wave
Changes on Root mean square standard deviation (RMSSD) parameter
Time frame: 12 minutes
Whether or not HRV parameter (RMSSD) improve following tongue and tragus stimulation will be assessed by photopletismographic wave
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 12 Aug 2024.
- Derived from this study: PubMed 39428464Monaco A, Cattaneo R, Di Nicolantonio S, Strada M, Pietropaoli D, Ortu E. Effects of trigeminal neurostimulation on heart rate variability: comparing cutaneous (Tragus) and tongue (Antero-Dorsal mucosa) stimulation. BMC Oral Health. 2024 Oct 20;24(1):1257. doi: 10.1186/s12903-024-04914-2.
- Individual participant dataSharing planned: No
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Recruiting
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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 device that stimulates the dorsal surface of the tongue and device that stimulates the tragus in people with Arousal, Confusional, run by University of L'Aquila at 1 site in Italy.
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 2 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 12 Aug 2024. 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 Italy. 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. 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?
Changes on Low Frequency parameter (LF) (time frame: 12 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06549205, which also lists 1 linked publication.
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 12 Aug 2024.