No Condition Salivary Alpha AmylaseNCT03854539
Salivary Alpha Amylase as a Biomarker of Transdermal Vagus Nerve Stimulation
A study testing Transdermal Vagus Nerve Stimulation in people with No Condition Salivary Alpha Amylase, run by Arkansas Tech University at 1 site in United States.
Trial summary
The proposed project tests the hypothesis that salivary alpha amylase concentration is a reliable biomarker of the effect of transdermal vagus nerve stimulation (tVNS) in humans. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- No Condition Salivary Alpha Amylase
- What is being tested?
- Transdermal Vagus Nerve Stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2018to 8 Jun 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Tech University
Russellville, Arkansas, 72801
About this study
The proposed project tests the hypothesis that salivary alpha amylase concentration is a reliable biomarker of the effect of transdermal vagus nerve stimulation (tVNS) in humans.
Read the detailed description
The study examines the capacity of tVNS to alter the concentrations of salivary alpha amylase. Changes in salivary alpha amylase concentrations reflect alteration of CNS structures anatomically linked to the vagus, thus alertation of alpha amylase would indicate the efficacy of tVNS. This study is intended to study basic mechanisms and is not directed toward the treatment of any disease state. Particapants taking part in the study will spend about one hour in a single session.
- Conditions
- No Condition Salivary Alpha Amylase
- Being tested
- Transdermal Vagus Nerve Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal Vagus Nerve StimulationOther
intermittent transdermal stimulation of the aurical vagus
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation 0.5 | Experimental | 0.5 mA intermittent transdermal stimulation of the aurical vagus stimulation 30 seconds on/30 seconds off for five cycles Receives: Other: Transdermal Vagus Nerve Stimulation |
| Sham Stimulation | Sham comparator | 0.5mA intermittent transdermal stimulation of the aurical vagus stimulation5 Hz 30 seconds on/30 seconds off for five cycles Receives: Other: Transdermal Vagus Nerve Stimulation |
| No Stimulation | No intervention | 0.0 mA (sham) intermittent transdermal stimulation of the aurical vagus stimulation, 0 Hz 30 seconds on/30 seconds off for five cycles |
| Active Stimulation 1.0 | Experimental | 0.5 mA intermittent transdermal stimulation of the aurical vagus stimulation 30 seconds on/30 seconds off for five cycles. Receives: Other: Transdermal Vagus Nerve Stimulation |
| Active Stimulation 0.25 | Experimental | 0.25 mA intermittent transdermal stimulation of the aurical vagus stimulation 30 seconds on/30 seconds off for five cycles Receives: Other: Transdermal Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Salivary Alpha Amylase concentration.
Biomarker of autonomic arousal level
Measured: Within single one hour session change in concentration immediately prior to and following stimulation and 5 minutes post-stimulation
Secondary outcomes (1)
Change in Heart Rate Variability.
Change in beat to beat interval.
Measured: Within single one hour session change in heart rate variability immediately prior to and following stimulation period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start31 Mar 2018
- Primary completion8 Jun 2020
- Study completion8 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Condition Salivary Alpha AmylaseStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodney Roosevelt, Arkansas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854539
- Sponsor's protocol ID
- Roosevelt-1
- Status last verified
- Jun 2020
- First submitted
- 19 Apr 2018
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Alpha Amylase as a Biomarker of Transdermal Vagus Nerve Stimulation
- ClinicalTrials.gov ID
- NCT03854539
- Acronym / sponsor ID
- Roosevelt-1
- Conditions
- No Condition Salivary Alpha Amylase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Arkansas Tech UniversityUniversity, hospital or other
- Study start
- 31 Mar 2018 (actual)
- Primary completion
- 8 Jun 2020 (actual)
- Study completion
- 8 Jun 2020 (actual)
- First posted
- 26 Feb 2019 (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.
The proposed project tests the hypothesis that salivary alpha amylase concentration is a reliable biomarker of the effect of transdermal vagus nerve stimulation (tVNS) in humans.
Detailed description
The study examines the capacity of tVNS to alter the concentrations of salivary alpha amylase. Changes in salivary alpha amylase concentrations reflect alteration of CNS structures anatomically linked to the vagus, thus alertation of alpha amylase would indicate the efficacy of tVNS. This study is intended to study basic mechanisms and is not directed toward the treatment of any disease state. Particapants taking part in the study will spend about one hour in a single session.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation 0.5 | Experimental | Other: Transdermal Vagus Nerve Stimulation0.5 mA intermittent transdermal stimulation of the aurical vagus stimulation 30 seconds on/30 seconds off for five cycles |
| Sham Stimulation | Sham comparator | Other: Transdermal Vagus Nerve Stimulation0.5mA intermittent transdermal stimulation of the aurical vagus stimulation5 Hz 30 seconds on/30 seconds off for five cycles |
| No Stimulation | No intervention | –0.0 mA (sham) intermittent transdermal stimulation of the aurical vagus stimulation, 0 Hz 30 seconds on/30 seconds off for five cycles |
| Active Stimulation 1.0 | Experimental | Other: Transdermal Vagus Nerve Stimulation0.5 mA intermittent transdermal stimulation of the aurical vagus stimulation 30 seconds on/30 seconds off for five cycles. |
| Active Stimulation 0.25 | Experimental | Other: Transdermal Vagus Nerve Stimulation0.25 mA intermittent transdermal stimulation of the aurical vagus stimulation 30 seconds on/30 seconds off for five cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy individuals
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| Transdermal Vagus Nerve Stimulationintermittent transdermal stimulation of the aurical vagus | Other | Active Stimulation 0.25, Active Stimulation 0.5, Active Stimulation 1.0, Sham Stimulation |
Primary outcome
Change in Salivary Alpha Amylase concentration.
Time frame: Within single one hour session change in concentration immediately prior to and following stimulation and 5 minutes post-stimulation
Biomarker of autonomic arousal level
1 secondary outcome
Change in Heart Rate Variability.
Time frame: Within single one hour session change in heart rate variability immediately prior to and following stimulation period.
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 18 Jun 2020.
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 Transdermal Vagus Nerve Stimulation in people with No Condition Salivary Alpha Amylase, run by Arkansas Tech University at 1 site in United States.
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 1 inclusion and 1 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 18 Jun 2020. 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 United States. 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?
Change in Salivary Alpha Amylase concentration. (time frame: Within single one hour session change in concentration immediately prior to and following stimulation and 5 minutes post-stimulation). 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 18 Jun 2020.