Stress and Sleep Study

NCT05218109 | Completed Results FDA Device

• 1 other identifier: IRB202101724
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Acceptability of the Combined tVNS + Mindfulness Intervention as Assessed by Participant Self-report of Acceptability Using the Acceptability of Intervention Measure (AIM)

  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.

  Assessed in the tVNS + mindfulness groups and sham + mindfulness groups at Week 2

• Sleep Quality as Assessed by Participant Self-report on the Pittsburgh Sleep Quality Index (PSQI)

  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).

  Assessed at the end of the intervention phase (Week 4)

• Perceived Stress as Assessed by Participant Self-report on the Perceived Stress Scale (PSS)

  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).

  Assessed at the end of the intervention phase (Week 4)

Study Arms (4)

tVNS + mindfulness

EXPERIMENTAL

Transcutaneous vagus nerve stimulation plus behavioral: mindfulness

Device: tVNS; Behavioral: Mindfulness

Sham + mindfulness

SHAM COMPARATOR

Sham transcutaneous vagus nerve stimulation plus behavioral: mindfulness

Behavioral: Mindfulness; Device: sham tVNS

Mindfulness only

ACTIVE COMPARATOR

Behavioral: Mindfulness

Control

ACTIVE COMPARATOR

Control number puzzle task delivered via mobile device

Other: Number Puzzle

Interventions

tVNS DEVICE

transcutaneous vagus nerve stimulation

tVNS + mindfulness

Mindfulness BEHAVIORAL

Brightmind mobile mindfulness application

Mindfulness only; Sham + mindfulness; tVNS + mindfulness

sham tVNS DEVICE

sham transcutaneous vagus nerve stimulation

Sham + mindfulness

Number Puzzle OTHER

Control number puzzle task delivered via mobile device

Control

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Undergraduate student (ages 18-30)
• Must own a smartphone
• Must be able to read and write English

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32601, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Sarah Bottari, M.S.
• Organization: University of Florida

sbottari@ufl.edu

(352) 273-6455

Study Officials

• Sarah Bottari, M.S.

  University of Florida

  PRINCIPAL INVESTIGATOR

• Liva LaMontagne, Dr. Psych.

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: February 1, 2022
• Study Start: February 9, 2022
• Primary Completion: April 28, 2023
• Study Completion: May 29, 2023
• Last Updated: April 4, 2024
• Results First Posted: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)