Let´s Talk About Sleep in College Student (NCT05265494) | Clinical Trial Compass
CompletedNot Applicable
Let´s Talk About Sleep in College Student
Spain40 participantsStarted 2021-11-15
Plain-language summary
The concern about the quality of sleep of university students, future professionals of the world, must be crucial for the scientific community, as well as for university professors and professors. Innovative electrotherapy technologies such as non-invasive neuromodulation NESA are demonstrating effects on improving sleep quality, concentration and stress, so the objective of this project is to carry out a triple-blind randomized clinical trial with first-year science science students. health from three universities. The design is made up of an intervention group with NESA technology and another control group in each of the centers. Where the quality of sleep, perception of stress, cortisol levels in saliva and academic performance will be analyzed.
This multicenter project hopes to demonstrate that non-invasive NESA neuromodulation can be a preventive treatment for the maintenance of sleep quality during stressful periods such as university exams, as well as being able to modulate perceived stress and translate into an improvement in student performance.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy people
* Be enrolled in a degree in health sciences at the partner universities in the study in the first year.
* Optimal cognitive abilities and mentally competent to participate in the study.
* In cognitive conditions to complete the study questionnaires
* Have an optimal command of the Spanish language to complete the questionnaires.
* Signing of the informed consent for participation
Exclusion Criteria:
* Present some of the contraindications for a treatment with NESA XSIGNAL®: Pacemaker or other electrical surgical device, internal bleeding, do not apply electrodes on skin in poor condition, with ulcerations or wounds, acute febrile processes, pregnancy, acute thrombophlebitis and / or phobia to electricity, and pregnant.
* Combine another pharmacological treatment that influences the variables to be evaluated during the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial measured both sleep quality and saliva cortisol levels in college students — can you help me understand what the connection between stress hormones and sleep disturbance means for my own situation, and whether my cortisol levels might be worth testing?
2Since this trial has already been completed, is there any published data or results from it that you think would be relevant to my sleep and stress concerns?
3This study focused specifically on college students — do you think the findings would apply to someone in my age group or life situation, or are there other studies better suited to my circumstances?
4Given that this trial didn't involve a drug or device (it has no listed phase), what kind of intervention do you think it was testing, and could a similar approach — like a sleep education program — be something worth trying for me before considering medication?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sleep quality
Timeframe: At the first consultation and through study completion, 5 weeks
2
Salival Cortisol
Timeframe: At the first consultation and through study completion, 5 weeks