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Stress and Sleep Study

NCT05218109 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2024-04-04

Study results available
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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.

Conditions

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

Interventions

DEVICE

tVNS

transcutaneous vagus nerve stimulation

BEHAVIORAL

Mindfulness

Brightmind mobile mindfulness application

DEVICE

sham tVNS

sham transcutaneous vagus nerve stimulation

OTHER

Number Puzzle

Control number puzzle task delivered via mobile device

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Sarah Bottari, M.S. · University of Florida

  • Liva LaMontagne, Dr. Psych. · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-09
Primary Completion
2023-04-28
Completion
2023-05-29
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05218109 on ClinicalTrials.gov