Stress and Sleep Study

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

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.

Study Overview

• Status: Completed
• Conditions: Stress, Psychological; Sleep; Vagus Nerve Stimulation; Mindfulness; Transcutaneous Electric Nerve Stimulation
• Intervention / Treatment: Device: tVNS; Behavioral: Mindfulness; Device: sham tVNS; Other: Number Puzzle

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32601
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tVNS + mindfulness; Transcutaneous vagus nerve stimulation plus behavioral: mindfulness	Device: tVNS; transcutaneous vagus nerve stimulation; Behavioral: Mindfulness; Brightmind mobile mindfulness application
Sham Comparator: Sham + mindfulness; Sham transcutaneous vagus nerve stimulation plus behavioral: mindfulness	Behavioral: Mindfulness; Brightmind mobile mindfulness application; Device: sham tVNS; sham transcutaneous vagus nerve stimulation
Active Comparator: Mindfulness only	Behavioral: Mindfulness; Brightmind mobile mindfulness application
Active Comparator: Control; Control number puzzle task delivered via mobile device	Other: Number Puzzle; Control number puzzle task delivered via mobile device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	Assessed at the end of the intervention phase (Week 4)

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Sarah Bottari, M.S., University of Florida; Principal Investigator: Liva LaMontagne, Dr. Psych., University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2022
• Primary Completion (Actual): April 28, 2023
• Study Completion (Actual): May 29, 2023

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: IRB202101724

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes