Back to resultsStress and Sleep Study
Primary Purpose
Stress, Psychological, Sleep, Transcutaneous Electric Nerve Stimulation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tVNS
Mindfulness
sham tVNS
Number Puzzle
Sponsored by
About this trial
This is an interventional other trial for Stress, Psychological
Eligibility Criteria
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)
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Sham Comparator
Active Comparator
Active Comparator
Arm Label
tVNS + mindfulness
Sham + mindfulness
Mindfulness only
Control
Arm Description
Transcutaneous vagus nerve stimulation plus behavioral: mindfulness
Sham transcutaneous vagus nerve stimulation plus behavioral: mindfulness
Control number puzzle task delivered via mobile device
Outcomes
Primary Outcome Measures
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). Total scores on the AIM range from 4-20, with higher scores indicating greater acceptability.
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).
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05218109
Brief Title
Stress and Sleep Study
Official Title
Non-pharmacological Interventions to Improve Stress and Sleep Among College Students
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 9, 2022 (Actual)
Primary Completion Date
April 28, 2023 (Actual)
Study Completion Date
May 29, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Sleep, Transcutaneous Electric Nerve Stimulation, Vagus Nerve Stimulation, Mindfulness
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tVNS + mindfulness
Arm Type
Experimental
Arm Description
Transcutaneous vagus nerve stimulation plus behavioral: mindfulness
Arm Title
Sham + mindfulness
Arm Type
Sham Comparator
Arm Description
Sham transcutaneous vagus nerve stimulation plus behavioral: mindfulness
Arm Title
Mindfulness only
Arm Type
Active Comparator
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control number puzzle task delivered via mobile device
Intervention Type
Device
Intervention Name(s)
tVNS
Intervention Description
transcutaneous vagus nerve stimulation
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
Brightmind mobile mindfulness application
Intervention Type
Device
Intervention Name(s)
sham tVNS
Intervention Description
sham transcutaneous vagus nerve stimulation
Intervention Type
Other
Intervention Name(s)
Number Puzzle
Intervention Description
Control number puzzle task delivered via mobile device
Primary Outcome Measure Information:
Title
Acceptability of the combined tVNS + mindfulness intervention as assessed by participant self-report of acceptability using the Acceptability of Intervention Measure (AIM)
Description
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). Total scores on the AIM range from 4-20, with higher scores indicating greater acceptability.
Time Frame
Baseline to the end of the intervention phase (4 weeks)
Title
Sleep quality as assessed by participant self-report on the Pittsburgh Sleep Quality Index (PSQI)
Description
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).
Time Frame
Baseline to the end of the intervention phase (4 weeks)
Title
Perceived stress as assessed by participant self-report on the Perceived Stress Scale (PSS)
Description
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).
Time Frame
Baseline to the end of the intervention phase (4 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Bottari, M.S.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liva LaMontagne, Dr. Psych.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32601
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Stress and Sleep Study
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