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Completed

NCT Number: NCT05218109

Stress and Sleep Study

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32601, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

tVNS

Device

transcutaneous vagus nerve stimulation

Mindfulness

Behavioral

Brightmind mobile mindfulness application

Sham tVNS

Device

sham transcutaneous vagus nerve stimulation

Number Puzzle

Other

Control number puzzle task delivered via mobile device

Primary outcomes

  1. 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.

  2. 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).

  3. 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).

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2022
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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