Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U24AG072699 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to understand the role of the vagus nerve in promoting social bonding by using a non-invasive stimulation technique called transcutaneous vagal nerve stimulation (tVNS). The investigators will investigate whether tVNS can improve emotional, physiological, and behavioral experiences during and after social interactions. Couples will be randomly assigned to receive either tVNS or a sham stimulation during gratitude expression and problem-solving discussions. The investigators will measure their subjective evaluations of the interactions and capture their physiological and behavioral synchrony. This research will shed light on the processes involved in social connection and explore the potential of tVNS as a tool to enhance bonding in close relationships.
As fundamental as the need to belong is to human survival and functioning, decades of research have shown that social connection is critical to emotional well-being. The current investigation seeks to use the knowledge and technological advances in the biomedical field to examine the causal role of the vagus nerve in promoting social bonding. Specifically, building on the recent evidence suggesting the effects of transcutaneous vagal nerve stimulation (tVNS) on improving social cognitive functioning, this study will examine the utility of tVNS in modulating emotional, physiological, and behavioral experiences during and after social interactions. The investigators will examine if romantic couple assigned to receive tVNS vs. active sham stimulation during two types of conversations (i.e., gratitude expression and problem-solving discussion) show differences in their experiences of the interactions. The study outcomes will include subjective evaluations of the interaction (e.g., felt emotions) and their physiological synchrony. This investigation will provide insights into the mechanistic processes that undergird social connection and, importantly, be the first to examine the potential utility of tVNS as an intervention tool for promoting social bonding within close relationships.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tVNS | Experimental | We will use a research edition of an auricular vagus nerve stimulator (tVNS RE, Vagus.net™, UK) that sends current-controlled stimulation in symmetric biphasic waveforms. The tVNS RE conforms to EU directive 93/42/EEC medical device standards and ISO/IEC 17050-1. This device consists of a handheld stimulator and an electrode clip. We will deliver stimulation at the individually calibrated intensity continuously during the interactions, and the default device settings we adopted were as follows: frequency = 30Hz, phase duration = 250μs, interphase interval = 50μs, and max voltage = 65V. In the active stimulation condition, both partners will have the stimulation clip attached to the outer auditory canal. |
|
| Sham tVNS | Sham Comparator | In the sham condition, both partners will have electrodes attached to the center of the left ear lobe. They will still receive stimulation but at a placement that should not activate the vagus nerve. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous vagal nerve stimulation | Device | The intervention consists of neurostimulation device that is programmed to a stimulus intensity at 0.5mA with a stimulation frequency of 25 Hz at the outer auditory canal. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Positive Affect | During the conversation, overall, I felt… (1: not at all positive, 7: extremely positive) | Once, self-reported in a survey immediately following conflict interaction, up to 10 minutes |
| Self-reported Negative Affect | During the conversation, overall, I felt… (1: not at all negative, 7: extremely negative) | Once, self-reported in a survey immediately following conflict interaction, up to 10 minutes |
| Respiratory Sinus Arrhythmia | RSA was assessed continuously throughout the conversation. | Continuously throughout conflict conversation |
| Interbeat Interval | IBI was assessed continuously throughout the conversation. | Continuously throughout the conflict conversation |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Nancy Friend Pritzker Psychiatry Building | San Francisco | California | 94107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Chung JM, Harari GM, Denissen JJ. Investigating the within-person structure and correlates of emotional experiences in everyday life using an emotion family approach. Journal of Personality and Social Psychology. 2022;122(6):1146-1189. |
Not provided
Not provided
There is currently no plan to make individual participant data available to other researchers.
Not provided
Not provided
Not provided
Not provided
Couples were randomly assigned to either the active or sham stimulation condition after confirming their eligibility and completing a background questionnaire at home. Although all sessions were completed, technical issues (e.g., tVNS device malfunction) occurred in some cases. When this happened, the affected couple was excluded from the random assignment, and the next couple was reassigned to that condition.
A total of 80 couples (i.e., 160 participants) were recruited from February 2024.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active tVNS | We delivered stimulation at the individually calibrated intensity continuously during the interactions, and the default device settings we adopted were as follows: frequency = 30Hz, phase duration = 250μs, interphase interval = 50μs, and max voltage = 65V. In the active stimulation condition, both partners will have the stimulation clip attached to the outer auditory canal. In the sham stimulation condition, they will have the stimulation clip attached to their earlobe. |
| FG001 | Sham tVNS | In the sham condition, both partners will have electrodes attached to the center of the left ear lobe. They will still receive stimulation but at a placement that should not activate the vagus nerve. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
After excluding five individuals whose physiological data during the conflict were unavailable and one whose baseline RSA was unavailable, our final analytic sample consisted of 134 individuals.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active tVNS | We delivered stimulation at the individually calibrated intensity continuously during the interactions, and the default device settings we adopted were as follows: frequency = 30Hz, phase duration = 250μs, interphase interval = 50μs, and max voltage = 65V. In the active stimulation condition, both partners will have the stimulation clip attached to the outer auditory canal. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Self-reported Positive Affect | During the conversation, overall, I felt… (1: not at all positive, 7: extremely positive) | Our analysis included 134 participants with complete physiological and self-report data. Missing data resulted from session failures (e.g., unstable or missing physiological measurements) or survey non-response | Posted | Mean | Standard Deviation | units on a scale | Once, self-reported in a survey immediately following conflict interaction, up to 10 minutes |
|
During a <2 hour laboratory session.
As the study was short (< 2 hours), did not involve any medical procedures, and recruited healthy couples with no major chronic disease, no serious adverse events were expected to occur. Previous research using similar procedures of stimulation (of similar intensity) also suggests that adverse events are unlikely. At most, mild forms of adverse events could occur in terms of physical irritation from stimulation and were monitored. Mortality/serious adverse events were not monitored/assessed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active tVNS | We will use a research edition of an auricular vagus nerve stimulator (tVNS RE, Vagus.net™, UK) that sends current-controlled stimulation in symmetric biphasic waveforms. The tVNS RE conforms to EU directive 93/42/EEC medical device standards and ISO/IEC 17050-1. This device consists of a handheld stimulator and an electrode clip. We will deliver stimulation at the individually calibrated intensity continuously during the interactions, and the default device settings we adopted were as follows: frequency = 30Hz, phase duration = 250μs, interphase interval = 50μs, and max voltage = 65V. In the active stimulation condition, both partners will have the stimulation clip attached to the outer auditory canal. Transcutaneous vagal nerve stimulation: The intervention consists of neurostimulation device that is programmed to a stimulus intensity at 0.5mA with a stimulation frequency of 25 Hz at the outer auditory canal. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yoobin Park | University of California, San Francisco | 6289461325 | yoobin.park@ucsf.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2025 | Mar 25, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 23, 2024 | Mar 26, 2025 | ICF_001.pdf |
Not provided
Not provided
Not provided
Couple dyads will be randomly assigned to receive either tVNS or sham stimulation.
Not provided
Not provided
Participant couples will be blinded to their condition. Experimenters running the study will not be blinded since tVNS administration currently requires their knowledge of the condition.
| BG001 | Sham tVNS | In the sham condition, both partners will have electrodes attached to the center of the left ear lobe. They will still receive stimulation but at a placement that should not activate the vagus nerve. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Relationship duration | how long the couple has been together in years | Mean | Standard Deviation | Years |
|
| OG001 | Sham tVNS | In the sham condition, both partners will have electrodes attached to the center of the left ear lobe. They will still receive stimulation but at a placement that should not activate the vagus nerve. |
|
|
| Primary | Self-reported Negative Affect | During the conversation, overall, I felt… (1: not at all negative, 7: extremely negative) | Our analysis included 134 participants with complete physiological and self-report data. Missing data resulted from session failures (e.g., unstable or missing physiological measurements) or survey non-response | Posted | Mean | Standard Deviation | units on a scale | Once, self-reported in a survey immediately following conflict interaction, up to 10 minutes |
|
|
|
| Primary | Respiratory Sinus Arrhythmia | RSA was assessed continuously throughout the conversation. | Our analysis included 134 participants with complete physiological and self-report data. Missing data resulted from session failures (e.g., unstable or missing physiological measurements) or survey non-response | Posted | Mean | Standard Error | ms | Continuously throughout conflict conversation |
|
|
|
| Primary | Interbeat Interval | IBI was assessed continuously throughout the conversation. | Our analysis included 134 participants with complete physiological and self-report data. Missing data resulted from session failures (e.g., unstable or missing physiological measurements) or survey non-response | Posted | Mean | Standard Deviation | ms | Continuously throughout the conflict conversation |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 160 |
| EG001 | Sham tVNS | In the sham condition, both partners will have electrodes attached to the center of the left ear lobe. They will still receive stimulation but at a placement that should not activate the vagus nerve. Transcutaneous vagal nerve stimulation: The intervention consists of neurostimulation device that is programmed to a stimulus intensity at 0.5mA with a stimulation frequency of 25 Hz at the outer auditory canal. | 0 | 0 | 0 | 0 | 0 | 160 |
Not provided
Not provided