Stress and Sleep Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Sleep, Stress, Psychological, Transcutaneous Electric Nerve Stimulation, Vagus Nerve Stimulation, Mindfulness

Intervention / Treatment
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* Device: tVNS
* Behavioral: Mindfulness
* Device: sham tVNS
* Other: Number Puzzle


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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). Total scores on the AIM range from 4-20, with higher scores indicating greater acceptability. | Baseline to the end of the intervention phase (4 weeks) | 
| 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). | Baseline to the end of the intervention phase (4 weeks) | 
| 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). | Baseline to the end of the intervention phase (4 weeks) |