N/A N=76 Randomized Single-blind Other

Stress and Sleep Study

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

Bottom Line

View on ClinicalTrials.gov: NCT05218109 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2024

Primary outcome: 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 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: tVNS (Device); Mindfulness (Behavioral); sham tVNS (Device); Number Puzzle (Other)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: Apr 2023

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	—

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.

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)

View full record on ClinicalTrials.gov →

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.