Stress Clinical Trial
— USLEEPOfficial title:
Let´s Talk About Sleep in College Student: an Innovative Treatment Based on Non-invasive Neuromodulation to Enhance the Sleep Quality and Academic Efficiency: Randomised Controlled Trial" (USLEEP)
Verified date | January 2023 |
Source | University of Las Palmas de Gran Canaria |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | January 16, 2023 |
Est. primary completion date | January 16, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Raquel Irina Medina Ramirez | Las Palmas De Gran Canaria | Las Palmas |
Spain | María Miana | Madrid |
Lead Sponsor | Collaborator |
---|---|
University of Las Palmas de Gran Canaria | Alfonso X El Sabio University, University of Alcala, University Pontifical of Salamanca |
Spain,
Escobar-Cordoba F, Eslava-Schmalbach J. [Colombian validation of the Pittsburgh Sleep Quality Index]. Rev Neurol. 2005 Feb 1-15;40(3):150-5. Spanish. — View Citation
Gaultney JF. The prevalence of sleep disorders in college students: impact on academic performance. J Am Coll Health. 2010;59(2):91-7. doi: 10.1080/07448481.2010.483708. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sleep quality | Through a validated sleep quality perception questionnaire, Pittsburgh questionnaire. the Pittsburgh index scored by the higher the total score, the worse the quality of sleep. In this way, a total score less than or equal to five indicates that, in general, your quality of sleep is optimal, while a total score greater than five suggests that you have more or less serious sleep problems. | At the first consultation and through study completion, 5 weeks | |
Primary | Salival Cortisol | Through the Soma OFC II cube. The analysis will be performed in real time through the collection of saliva, it is not affected by recent food and drink; Once the swab is in the buffer, your sample is stable for months. It is a validated instrument | At the first consultation and through study completion, 5 weeks | |
Secondary | Academic Stress | The questionnaire Academic Stress Questionnaire at University (Time Management Behavior Questionnaire for University Students, in english). It assesses possible stressful situations in the university environment and consists of a total of 21 items. The participants' responses indicate the level of perceived stress in each situation using a Likert-type response scale with 5 options ranging from "no stress" (1) to "a lot of stress" (5). .
The scale evaluates four complementary dimensions: Establishing objectives and priorities. Its response range lies between 10-50, and its internal consistency is .90. Time management tools. A response range between 11-55 and an internal consistency of .88. Preferences for disorganization. A response range between 8-40 and an internal consistency of .70. Perception of control over time. A response range between 5-25 and an internal consistency of .68 |
At the first consultation and through study completion, 5 weeks | |
Secondary | Coping with academic stress | The Academic stress coping scale, known as A-CEA (Escala de afrontamiento del estrés académico, in spanish) (González Cabanach et al., 2010), is a subscale of the CEAU questionnaire. It evaluates the establishment of adequate time periods for studying (daily, weekly, monthly), the effective use of time, setting realistic objectives, and the characteristics of the setting in which the subject usually studies and does his or her academic activities. It consists of 8 items (e.g., "I make sure I am caught up on the material and projects"), with a response range between 8-56 and an internal consistency of .79. | At the first consultation and through study completion, 5 weeks | |
Secondary | Questionnaire of sociodemographic variables | A third questionnaire to collect necessary information on sociodemographic variables such as age, gender, place of residence and type of home. This questionnaire also aims to collect some data regarding their academic life, such as the average grade for access to university and the degree completed. The ad-hoc questionnaire consists of a total of 11 items and all questions are made in a clear and concise manner so that the answer is free from ambiguity. | At the first consultation and through study completion, 5 weeks | |
Secondary | ACADEMIC PERFORMANCE | The final average grade of the first academic semester will be analyzed comparing by groups. | Through study completion, 5 weeks |
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