NCT05218109

Stress and Sleep Study

Completed NA Results posted Last updated 4 April 2024

What this trial tests

NA trial testing tVNS in Stress, Psychological in 76 participants. Completed in 29 May 2023.

Timeline

9 February 2022

Primary endpoint
28 April 2023

29 May 2023

Quick facts

Lead sponsor	University of Florida
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	76
Start date	9 February 2022
Primary completion	28 April 2023
Estimated completion	29 May 2023
Sites	1 location across United States

Drugs / interventions tested

• tVNS
• Mindfulness
• sham tVNS
• Number Puzzle

Conditions studied

• Stress, Psychological — all drugs for Stress, Psychological →
• Sleep — all drugs for Sleep →
• Transcutaneous Electric Nerve Stimulation — all drugs for Transcutaneous Electric Nerve Stimulation →
• Vagus Nerve Stimulation — all drugs for Vagus Nerve Stimulation →

Sponsor

University of Florida

Who can join

Adults 18 to 30, any sex, with Stress, Psychological or Sleep. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Acceptability of the Combined tVNS + Mindfulness Intervention as Assessed by Participant Self-report of Acceptability Using the Acceptability of Intervention Measure (AIM) Primary · Assessed in the tVNS + mindfulness groups and sham + mindfulness groups at Week 2

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.

Group	Value	95% CI
tVNS + Mindfulness	4.08	± 0.40
Sham + Mindfulness	3.37	± 1.15

Sleep Quality as Assessed by Participant Self-report on the Pittsburgh Sleep Quality Index (PSQI) Primary · Assessed at the end of the intervention phase (Week 4)

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).

Group	Value	95% CI
tVNS + Mindfulness	6.23	± 2.62
Sham + Mindfulness	8.29	± 2.61
Mindfulness Only	7.84	± 2.32
Control	8.21	± 2.78

Perceived Stress as Assessed by Participant Self-report on the Perceived Stress Scale (PSS) Primary · Assessed at the end of the intervention phase (Week 4)

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).

Group	Value	95% CI
tVNS + Mindfulness	11.46	± 5.81
Sham + Mindfulness	13.36	± 6.34
Mindfulness Only	14.47	± 5.58
Control	16.42	± 8.66

Adverse events — posted to ClinicalTrials.gov

Time frame: During participants' active participation in the study (4 weeks). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

tVNS + Mindfulness

Serious: 0/16 (0%)

Deaths: 0/16

Sham + Mindfulness

Serious: 0/20 (0%)

Deaths: 0/20

Mindfulness Only

Serious: 0/20 (0%)

Deaths: 0/20

Control

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (1 terms — click to expand)

Reaction	System	tVNS + Mindfulness	Sham + Mindfulness	Mindfulness Only	Control
Uncomfortable variation in stimulation intensity at stimulation site	Product Issues	—	—	—	—

Data from ClinicalTrials.gov NCT05218109 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.