Stress, PsychologicalNCT05218109

Stress and Sleep Study

A study testing tVNS, Mindfulness and Number Puzzle in people with Stress, Psychological and Sleep, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This between-subject, longitudinal pilot study in healthy college students aims to explore the acceptability and preliminary outcomes of two novel and complementary interventions that may improve stress and sleep: transcutaneous vagus nerve stimulation (tVNS) and a mobile mindfulness intervention. Read more about this study

Who is it for?: Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Stress, Psychological, Sleep, Transcutaneous Electric Nerve Stimulation
What is being tested?: tVNS, Mindfulness and Number Puzzle
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 76 participants
Where: 1 siteUnited States
Study dates: 9 Feb 2022to 29 May 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Undergraduate student (ages 18-30)
Must own a smartphone
Must be able to read and write English

Who cannot join

Major medical illnesses including diagnosed severe neurological illnesses (e.g., stroke, seizure history), medical conditions associated with neurological effects (e.g. heart, kidney disease), autoimmune disorders, and severe psychiatric diseases (e.g., schizophrenia)
Pregnancy
History of brain surgery, tumor, intracranial metal implantation, pacemakers or other implanted devices
History of adverse reaction to electrical nerve stimulation
Prescribed sleep medications and/or psychotropic medications
Illicit or prescription drug abuse within the last two months (marijuana or alcohol abuse >2 weeks out will be acceptable for inclusion)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Florida
Gainesville, Florida, 32601

Other trials in United States

About this study

Official title: Non-pharmacological Interventions to Improve Stress and Sleep Among College Students

Conditions: Stress, Psychological, Sleep, Transcutaneous Electric Nerve Stimulation, Vagus Nerve Stimulation, Mindfulness
Being tested: tVNS, Mindfulness, sham tVNS, Number Puzzle
Medical subject headings: Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tVNSDevice
transcutaneous vagus nerve stimulation
MindfulnessBehavioural
Brightmind mobile mindfulness application
sham tVNSDevice
sham transcutaneous vagus nerve stimulation
Number PuzzleOther
Control number puzzle task delivered via mobile device

Study groups in NCT05218109
Study group	Role	What they receive
tVNS + mindfulness	Experimental	Transcutaneous vagus nerve stimulation plus behavioral: mindfulness Receives: Device: tVNS; Behavioral: Mindfulness
Sham + mindfulness	Sham comparator	Sham transcutaneous vagus nerve stimulation plus behavioral: mindfulness Receives: Behavioral: Mindfulness; Device: sham tVNS
Mindfulness only	Active comparator	Not described Receives: Behavioral: Mindfulness
Control	Active comparator	Control number puzzle task delivered via mobile device Receives: Other: Number Puzzle

What is being measured

The primary outcome is the main question the study is designed to answer.

Acceptability of the Combined tVNS + Mindfulness Intervention as Assessed by Participant Self-report of Acceptability Using the Acceptability of Intervention Measure (AIM)
The AIM (Weiner et al., 2017) is a brief 4-item scale measuring the degree to which participants believe an intervention is acceptable. The response scale for each item ranges from 1 (completely disagree) to 5 (completely agree). Responses from the 4 items are averaged to yield total scores ranging from 1-5, with higher scores indicating greater acceptability.
Measured: Assessed in the tVNS + mindfulness groups and sham + mindfulness groups at Week 2
Sleep Quality as Assessed by Participant Self-report on the Pittsburgh Sleep Quality Index (PSQI)
The PSQI (Buysse et al., 1989) contains 19 self-rated items that are combined to form seven component scores, each of which has a range from 0-3 points. For each component, a score of 0 indicates no difficulty, while a score of 3 indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range from 0-21 points (0 = best sleep quality, 21 = poorest sleep quality).
Measured: Assessed at the end of the intervention phase (Week 4)
Perceived Stress as Assessed by Participant Self-report on the Perceived Stress Scale (PSS)
The PSS (Cohen et al., 1994) is a 10-item questionnaire measuring the degree to which situations in one's life are appraised as stressful. In particular, it gauges how unpredictable, uncontrollable, and overloaded respondents find their lives. Participants rate each item on a scale of 0 (never) to 4 (very often), and total scores range from 0-40 (0 = least perceived stress, 40 = most perceived stress).
Measured: Assessed at the end of the intervention phase (Week 4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Feb 202229 May 2023

First posted1 Feb 2022
Study start9 Feb 2022
Primary completion28 Apr 2023
Study completion29 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05218109
Sponsor's protocol ID: IRB202101724
Status last verified: Apr 2024
First submitted: 3 Jan 2022
Last updated: 4 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-pharmacological Interventions to Improve Stress and Sleep Among College Students
ClinicalTrials.gov ID: NCT05218109
Acronym / sponsor ID: IRB202101724
Conditions: Stress, Psychological, Sleep, Transcutaneous Electric Nerve Stimulation, Vagus Nerve Stimulation, Mindfulness
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Study start: 9 Feb 2022 (actual)
Primary completion: 28 Apr 2023 (actual)
Study completion: 29 May 2023 (actual)
First posted: 1 Feb 2022 (actual)
Results: Posted 4 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
tVNS + mindfulness	Experimental	Device: tVNS, Behavioral: MindfulnessTranscutaneous vagus nerve stimulation plus behavioral: mindfulness
Sham + mindfulness	Sham comparator	Behavioral: Mindfulness, Device: sham tVNSSham transcutaneous vagus nerve stimulation plus behavioral: mindfulness
Mindfulness only	Active comparator	Behavioral: Mindfulness
Control	Active comparator	Other: Number PuzzleControl number puzzle task delivered via mobile device

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Undergraduate student (ages 18-30)
Must own a smartphone
Must be able to read and write English

Key exclusion criteria (6 listed)

Major medical illnesses including diagnosed severe neurological illnesses (e.g., stroke, seizure history), medical conditions associated with neurological effects (e.g. heart, kidney disease), autoimmune disorders, and severe psychiatric diseases (e.g., schizophrenia)
Pregnancy
History of brain surgery, tumor, intracranial metal implantation, pacemakers or other implanted devices
History of adverse reaction to electrical nerve stimulation
Prescribed sleep medications and/or psychotropic medications

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
tVNStranscutaneous vagus nerve stimulation	Device	tVNS + mindfulness
MindfulnessBrightmind mobile mindfulness application	Behavioural	Mindfulness only, Sham + mindfulness, tVNS + mindfulness
sham tVNSsham transcutaneous vagus nerve stimulation	Device	Sham + mindfulness
Number PuzzleControl number puzzle task delivered via mobile device	Other	Control

Primary outcome

Acceptability of the Combined tVNS + Mindfulness Intervention as Assessed by Participant Self-report of Acceptability Using the Acceptability of Intervention Measure (AIM)
Time frame: Assessed in the tVNS + mindfulness groups and sham + mindfulness groups at Week 2
The AIM (Weiner et al., 2017) is a brief 4-item scale measuring the degree to which participants believe an intervention is acceptable. The response scale for each item ranges from 1 (completely disagree) to 5 (completely agree). Responses from the 4 items are averaged to yield total scores ranging from 1-5, with higher scores indicating greater acceptability.
Sleep Quality as Assessed by Participant Self-report on the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Assessed at the end of the intervention phase (Week 4)
The PSQI (Buysse et al., 1989) contains 19 self-rated items that are combined to form seven component scores, each of which has a range from 0-3 points. For each component, a score of 0 indicates no difficulty, while a score of 3 indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range from 0-21 points (0 = best sleep quality, 21 = poorest sleep quality).
Perceived Stress as Assessed by Participant Self-report on the Perceived Stress Scale (PSS)
Time frame: Assessed at the end of the intervention phase (Week 4)
The PSS (Cohen et al., 1994) is a 10-item questionnaire measuring the degree to which situations in one's life are appraised as stressful. In particular, it gauges how unpredictable, uncontrollable, and overloaded respondents find their lives. Participants rate each item on a scale of 0 (never) to 4 (very often), and total scores range from 0-40 (0 = least perceived stress, 40 = most perceived stress).

Results and safety

Results posted to the registry on 4 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
tVNS + Mindfulness	16	14
Sham + Mindfulness	20	14
Mindfulness Only	20	17
Control	20	20

Primary outcome: Acceptability of the Combined tVNS + Mindfulness Intervention as Assessed by Participant Self-report of Acceptability Using the Acceptability of Intervention Measure (AIM)

Time frame: Assessed in the tVNS + mindfulness groups and sham + mindfulness groups at Week 2. Mean (Standard Deviation). Unit: units on a scale

Measure	tVNS + Mindfulness n = 12	Sham + Mindfulness n = 14
Value	4.08 (0.40)	3.37 (1.15)

Population analysed: Enrolled participants in the tVNS + mindfulness groups and sham + mindfulness groups who completed the Week 2 questionnaires at the appropriate timeframe were included in the analysis. Results are not reported for the Mindfulness only and Control groups, as these participants did not receive the tVNS portion of the combined intervention. Therefore, they did not complete the AIM measure asking about acceptability of the tVNS intervention and data was not available to report on for those groups.

Primary outcome: Sleep Quality as Assessed by Participant Self-report on the Pittsburgh Sleep Quality Index (PSQI)

Time frame: Assessed at the end of the intervention phase (Week 4). Mean (Standard Deviation). Unit: units on a scale

Measure	tVNS + Mindfulness n = 13	Sham + Mindfulness n = 14	Mindfulness Only n = 19	Control n = 19
Value	6.23 (2.62)	8.29 (2.61)	7.84 (2.32)	8.21 (2.78)

Population analysed: Enrolled participants who completed the Week 4 questionnaires during an appropriate timeframe were included in this analysis.

Primary outcome: Perceived Stress as Assessed by Participant Self-report on the Perceived Stress Scale (PSS)

Time frame: Assessed at the end of the intervention phase (Week 4). Mean (Standard Deviation). Unit: units on a scale

Measure	tVNS + Mindfulness n = 13	Sham + Mindfulness n = 14	Mindfulness Only n = 19	Control n = 19
Value	11.46 (5.81)	13.36 (6.34)	14.47 (5.58)	16.42 (8.66)

Population analysed: Enrolled participants who completed the Week 4 questionnaires during the appropriate timeframe were included in the analysis.

Adverse events

Time frame: During participants' active participation in the study (4 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
tVNS + Mindfulness	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Sham + Mindfulness	0 of 20 (0%)	3 of 20 (15%)	0 of 20
Mindfulness Only	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Control	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Sarah Bottari, M.S. principal investigator

University of Florida

Liva LaMontagne, Dr. Psych. principal investigator

University of Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing tVNS, Mindfulness and Number Puzzle in people with Stress, Psychological and Sleep, run by University of Florida 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 3 inclusion and 6 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 Apr 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 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?

Yes. Results are posted in the registry (first posted 4 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Acceptability of the Combined tVNS + Mindfulness Intervention as Assessed by Participant Self-report of Acceptability Using the Acceptability of Intervention Measure (AIM) (time frame: Assessed in the tVNS + mindfulness groups and sham + mindfulness groups at Week 2). The study lists 3 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 NCT05218109.

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 Apr 2024; AzTrials last refreshed its copy on 27 Oct 2026.