N/A
Completed N=76
Stress and Sleep Study
Stress, Psychological · Sleep · Transcutaneous Electric Nerve Stimulation · Vagus Nerve Stimulation
Source: ClinicalTrials.gov NCT05218109 ↗
Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Acceptability of the Combined tVNS + Mindfulness Intervention as Assessed by Participant Self-report of Acceptability Using the Acceptability of Intervention Measure (AIM) — 4.08; 3.37 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability of the Combined tVNS + Mindfulness Intervention as Assessed by Participant Self-report of Acceptability Using the Acceptability of Intervention Measure (AIM) |
4.08; 3.37 | — |
| PRIMARY Sleep Quality as Assessed by Participant Self-report on the Pittsburgh Sleep Quality Index (PSQI) |
6.23; 8.29; 7.84; 8.21 | — |
| PRIMARY Perceived Stress as Assessed by Participant Self-report on the Perceived Stress Scale (PSS) |
11.46; 13.36; 14.47; 16.42 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT05218109). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.