Trial Outcomes & Findings for Stress and Sleep Study (NCT NCT05218109)

Last Updated: 2024-04-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

76 participants

Primary outcome timeframe

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

Results posted on

2024-04-04

Participant Flow

Participants were assigned to study arms/groups pseudo-randomly upon scheduling an intake appointment (prior to enrollment).

Participant milestones

Participant milestones
Measure	tVNS + Mindfulness Transcutaneous vagus nerve stimulation plus behavioral: mindfulness tVNS: transcutaneous vagus nerve stimulation Mindfulness: Brightmind mobile mindfulness application	Sham + Mindfulness Sham transcutaneous vagus nerve stimulation plus behavioral: mindfulness Mindfulness: Brightmind mobile mindfulness application sham tVNS: sham transcutaneous vagus nerve stimulation	Mindfulness Only Mindfulness: Brightmind mobile mindfulness application	Control Control number puzzle task delivered via mobile device Number Puzzle: Control number puzzle task delivered via mobile device
Overall Study STARTED	16	20	20	20
Overall Study Week 1	14	15	19	20
Overall Study Week 2	13	14	19	20
Overall Study Week 3	12	13	19	18
Overall Study Week 4	13	14	19	19
Overall Study Week 8 (Follow Up)	14	14	17	20
Overall Study COMPLETED	14	14	17	20
Overall Study NOT COMPLETED	2	6	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stress and Sleep Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	tVNS + Mindfulness n=15 Participants Transcutaneous vagus nerve stimulation plus behavioral: mindfulness tVNS: transcutaneous vagus nerve stimulation Mindfulness: Brightmind mobile mindfulness application	Sham + Mindfulness n=17 Participants Sham transcutaneous vagus nerve stimulation plus behavioral: mindfulness Mindfulness: Brightmind mobile mindfulness application sham tVNS: sham transcutaneous vagus nerve stimulation	Mindfulness Only n=20 Participants Mindfulness: Brightmind mobile mindfulness application	Control n=20 Participants Control number puzzle task delivered via mobile device Number Puzzle: Control number puzzle task delivered via mobile device	Total n=72 Participants Total of all reporting groups
Age, Continuous	20.67 years STANDARD_DEVIATION 2.38 • n=5 Participants	19.71 years STANDARD_DEVIATION 1.26 • n=7 Participants	19.95 years STANDARD_DEVIATION 1.73 • n=5 Participants	20.75 years STANDARD_DEVIATION 1.45 • n=4 Participants	20.26 years STANDARD_DEVIATION 1.74 • n=21 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	12 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	42 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	30 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants	9 Participants n=4 Participants	23 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	15 Participants n=7 Participants	12 Participants n=5 Participants	11 Participants n=4 Participants	49 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	18 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	34 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	11 Participants n=21 Participants
Pittsburg Sleep Quality Index (PSQI)	8.13 units on a scale STANDARD_DEVIATION 2.70 • n=5 Participants	9.29 units on a scale STANDARD_DEVIATION 2.71 • n=7 Participants	8.9 units on a scale STANDARD_DEVIATION 2.61 • n=5 Participants	7.25 units on a scale STANDARD_DEVIATION 3.00 • n=4 Participants	8.38 units on a scale STANDARD_DEVIATION 2.83 • n=21 Participants
Perceived Stress Scale (PSS)	14.87 units on a scale STANDARD_DEVIATION 5.59 • n=5 Participants	16.47 units on a scale STANDARD_DEVIATION 7.26 • n=7 Participants	14.80 units on a scale STANDARD_DEVIATION 5.15 • n=5 Participants	16.35 units on a scale STANDARD_DEVIATION 6.00 • n=4 Participants	15.64 units on a scale STANDARD_DEVIATION 5.95 • n=21 Participants

PRIMARY outcome

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

Population: Enrolled participants in the tVNS + mindfulness groups and sham + mindfulness groups who completed the Week 2 questionnaires at the appropriate timeframe were included in the analysis. Results are not reported for the Mindfulness only and Control groups, as these participants did not receive the tVNS portion of the combined intervention. Therefore, they did not complete the AIM measure asking about acceptability of the tVNS intervention and data was not available to report on for those groups.

Outcome measures

Outcome measures
Measure	tVNS + Mindfulness n=12 Participants Transcutaneous vagus nerve stimulation plus behavioral: mindfulness tVNS: transcutaneous vagus nerve stimulation Mindfulness: Brightmind mobile mindfulness application	Sham + Mindfulness n=14 Participants Sham transcutaneous vagus nerve stimulation plus behavioral: mindfulness Mindfulness: Brightmind mobile mindfulness application sham tVNS: sham transcutaneous vagus nerve stimulation	Mindfulness Only Mindfulness: Brightmind mobile mindfulness application	Control Control number puzzle task delivered via mobile device Number Puzzle: Control number puzzle task delivered via mobile device
Acceptability of the Combined tVNS + Mindfulness Intervention as Assessed by Participant Self-report of Acceptability Using the Acceptability of Intervention Measure (AIM)	4.08 units on a scale Standard Deviation 0.40	3.37 units on a scale Standard Deviation 1.15	—	—

PRIMARY outcome

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

Population: Enrolled participants who completed the Week 4 questionnaires during an appropriate timeframe were included in this analysis.

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).

Outcome measures

Outcome measures
Measure	tVNS + Mindfulness n=13 Participants Transcutaneous vagus nerve stimulation plus behavioral: mindfulness tVNS: transcutaneous vagus nerve stimulation Mindfulness: Brightmind mobile mindfulness application	Sham + Mindfulness n=14 Participants Sham transcutaneous vagus nerve stimulation plus behavioral: mindfulness Mindfulness: Brightmind mobile mindfulness application sham tVNS: sham transcutaneous vagus nerve stimulation	Mindfulness Only n=19 Participants Mindfulness: Brightmind mobile mindfulness application	Control n=19 Participants Control number puzzle task delivered via mobile device Number Puzzle: Control number puzzle task delivered via mobile device
Sleep Quality as Assessed by Participant Self-report on the Pittsburgh Sleep Quality Index (PSQI)	6.23 units on a scale Standard Deviation 2.62	8.29 units on a scale Standard Deviation 2.61	7.84 units on a scale Standard Deviation 2.32	8.21 units on a scale Standard Deviation 2.78

PRIMARY outcome

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

Population: Enrolled participants who completed the Week 4 questionnaires during the appropriate timeframe were included in the analysis.

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).

Outcome measures

Outcome measures
Measure	tVNS + Mindfulness n=13 Participants Transcutaneous vagus nerve stimulation plus behavioral: mindfulness tVNS: transcutaneous vagus nerve stimulation Mindfulness: Brightmind mobile mindfulness application	Sham + Mindfulness n=14 Participants Sham transcutaneous vagus nerve stimulation plus behavioral: mindfulness Mindfulness: Brightmind mobile mindfulness application sham tVNS: sham transcutaneous vagus nerve stimulation	Mindfulness Only n=19 Participants Mindfulness: Brightmind mobile mindfulness application	Control n=19 Participants Control number puzzle task delivered via mobile device Number Puzzle: Control number puzzle task delivered via mobile device
Perceived Stress as Assessed by Participant Self-report on the Perceived Stress Scale (PSS)	11.46 units on a scale Standard Deviation 5.81	13.36 units on a scale Standard Deviation 6.34	14.47 units on a scale Standard Deviation 5.58	16.42 units on a scale Standard Deviation 8.66

Adverse Events

tVNS + Mindfulness

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham + Mindfulness

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Mindfulness Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	tVNS + Mindfulness n=16 participants at risk Transcutaneous vagus nerve stimulation plus behavioral: mindfulness tVNS: transcutaneous vagus nerve stimulation Mindfulness: Brightmind mobile mindfulness application	Sham + Mindfulness n=20 participants at risk Sham transcutaneous vagus nerve stimulation plus behavioral: mindfulness Mindfulness: Brightmind mobile mindfulness application sham tVNS: sham transcutaneous vagus nerve stimulation	Mindfulness Only n=20 participants at risk Mindfulness: Brightmind mobile mindfulness application	Control n=20 participants at risk Control number puzzle task delivered via mobile device Number Puzzle: Control number puzzle task delivered via mobile device
Product Issues Uncomfortable variation in stimulation intensity at stimulation site	0.00% 0/16 • During participants' active participation in the study (4 weeks)	15.0% 3/20 • Number of events 3 • During participants' active participation in the study (4 weeks)	0.00% 0/20 • During participants' active participation in the study (4 weeks)	0.00% 0/20 • During participants' active participation in the study (4 weeks)

Additional Information

Sarah Bottari, M.S.

University of Florida

Phone: (352) 273-6455

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place