Stress and Sleep Study

Sleep Clinical Trial

Official title:

Non-pharmacological Interventions to Improve Stress and Sleep Among College Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05218109
• Other study ID #: IRB202101724
• Status: Completed
• Phase: N/A
• Start date: February 9, 2022
• Est. completion date: May 29, 2023

Study information

• Verified date: April 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 29, 2023
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Mindfulness
• Sleep
• Stress, Psychological
• Transcutaneous Electric Nerve Stimulation
• Vagus Nerve Stimulation

Intervention

Device:
• tVNS
transcutaneous vagus nerve stimulation

Behavioral:
• Mindfulness
Brightmind mobile mindfulness application

Device:
• sham tVNS
sham transcutaneous vagus nerve stimulation

Other:
• Number Puzzle
Control number puzzle task delivered via mobile device

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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)