The primary aim of this study is to assess the efficacy of taVNS in mitigating the acute stress response induced by the Maastricht Acute Stress Task (MAST) among healthy subjects, measured by cortisol levels in saliva samples.Secondary objectives…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Gezonde proefpersonen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is a significant reduction in the neuroendocrine stress
response, measured by saliva cortisol samples, in the taVNS group compared to
the sham treatment group following the MAST.
Secondary outcome
Secondary endpoints are:
- Subjective stress responses to the MAST following taVNS or sham treatment,
assessed through scores on the I-PANAS-SF and 0-100 Visual Analog Scales (VAS);
- Autonomic response to stress following taVNS or sham treatment and the MAST,
assessed using a combination of blood pressure monitoring, Fitbit smartwatch,
and the Shimmer3 GSR sensor;
- Stress responses in relation to potential affective symptoms and personality
traits, using the GAD-7, PHQ-9, and BFI;
- Number and severity of adverse events.
Background summary
Dysregulation of the autonomic nervous system (ANS) has been shown to be
associated with various diseases. Stress is a significant factor capable of
inducing such sympatico-vagal imbalance by favouring sympathetic responses.
Restoring normal vagal tone is a key objective in treating these conditions.
Transcutaneous auricular vagus nerve stimulation (taVNS) offers a non-invasive
approach to modulate the ANS, given the unique access point of the external
ear to the vagus nerve. This modulation can influence numerous physiological
processes and bodily states associated with information transfer between the
brain and the body. While previous studies show promising results, the precise
physiological impact of taVNS on vagal or autonomic function remains unclear. A
better understanding of the mechanisms of action for taVNS is essential for
implementing taVNS-based treatment strategies in everyday practice.
Study objective
The primary aim of this study is to assess the efficacy of taVNS in mitigating
the acute stress response induced by the Maastricht Acute Stress Task (MAST)
among healthy subjects, measured by cortisol levels in saliva samples.
Secondary objectives include:
- Evaluating taVNS*s potential to counteract stress-induced sympathetic
activation and thereby alleviate stress-related effects, including negative
affect, as measuring using the I-PANAS-SF questionnaire, and feelings of
stress, pain, and unpleasantness, as measured with 0-100 Visual Analog Scales
(VAS)
- Assessing its impact on autonomic outflow parameters, , using a blood
pressure monitor for blood pressure, and a FitBit smartwatch for heart rate
variability, and Shimmer3 GSR sensor for heart rate variability and skin
conductance. .
- Evaluating the relationship between stress responses and affective symptoms
and personality traits, utilizing the Generalized Anxiety Disorder 7-Item Scale
(GAD-7), Patient Health Questionnaire (PHQ-9), and the Big Five Inventory
(BFI).
Study design
This study concerns a single-centre, prospective, double-blind, randomized,
placebo-controlled interventional trial with a (1:1) parallel design, with all
measurements conducted at Maastricht University.
Intervention
Participants will be randomly assigned to either the taVNS or sham stimulation
group, administered 30 minutes before the MAST.
Study burden and risks
This study, involving 60 healthy volunteers aged 18-65 years, is a low-risk
interventional study. Participants will undergo two short visits: an initial
visit for obtaining written informed consent and completing (digital)
questionnaires, and a test day lasting 2-3 hours. During the test day,
participants will receive either 30 minutes of taVNS or sham stimulation,
followed by the 15-minute MAST. Participants will rate feelings of negative
affect using the I-PANAS-SF and assess their perceived stress, pain, and
unpleasantness using 0-100 Visual Analogue Scales (VASs)/ Saliva cortisol
samples will be taken at eight fixed time points, up to 55 minutes after the
MAST. The study does not involve incapacitated or minority groups. While
participants will not directly benefit, risks are minor and proportional to
scientific value. TaVNS is non-invasive, with no reported serious adverse
events. The MAST is a well-established research tool and is not expected to
induce negative effects beyond mild discomfort and emotional responses.
Additional procedures include administering questionnaires, collecting cortisol
saliva samples, and measuring autonomic parameters. All these procedures carry
minimal risks.
Universiteitssingel 50
Maastricht 6229ER
NL
Universiteitssingel 50
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
- Healthy participants (defined as those without a pre-existing medical
comorbidity)
- Aged between 18-65 years
- Ability to understand and speak the Dutch language.
Exclusion criteria
- Medical history or condition affecting the cardiovascular, respiratory,
urogenital, gastrointestinal/hepatic, haematologic/immunologic, HEENT (head,
ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal,
metabolic/nutritional, endocrine, neurological/psychiatric systems, as well as
prior major surgeries or ongoing laboratory abnormalities that could
potentially limit participation or completion of the study protocol;
- Any use of medication, especially those that may influence the autonomic
nervous system or the hypothalamus-pituitary-adrenal axis (e.g., beta-agonists
or corticosteroids), with the exception of contraceptives and paracetamol;
- Current or lifetime psychopathology (including PHQ-9 and GHD-7 scores > 10);
- Substance abuse (including excessive alcohol consumption);
- Smoking;
- Pregnancy, lactation, or intention to become pregnant during the study
period;
- Use of devices (e.g., cochlear implants) or other reasons (e.g. wounds,
permanent ear-piercing) which complicate the use of the tVNS device;
- Participation in another clinical study in which the MAST was used;
- Administration of investigational drugs or participation in any scientific
intervention study that might interfere with this study (to be determined by
the principal investigator) within 180 days preceding the commencement of the
study;
- Students and employees of Maastricht University are not precluded from
participation, unless they have a direct personal, professional or hierarchical
position with regards to any of the study team members or their department.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87188.068.24 |