Stress and Sleep Study

University of Florida

Status: Completed

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

Treatments: Other: Number Puzzle; Device: sham tVNS; Device: tVNS; Behavioral: Mindfulness

Study type: Interventional

Funder types: Other

Identifiers

NCT05218109

IRB202101724

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 4 patient groups

tVNS + mindfulness

Experimental group

Description:

Transcutaneous vagus nerve stimulation plus behavioral: mindfulness

Treatment:

Device: tVNS

Behavioral: Mindfulness

Sham + mindfulness

Sham Comparator group

Description:

Sham transcutaneous vagus nerve stimulation plus behavioral: mindfulness

Treatment:

Device: sham tVNS

Behavioral: Mindfulness

Mindfulness only

Active Comparator group

Treatment:

Behavioral: Mindfulness

Control

Active Comparator group

Description:

Control number puzzle task delivered via mobile device

Treatment:

Other: Number Puzzle