Clinical trial NCT05265494: Let´s Talk About Sleep in College Student
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Sleep Disturbance
Keywords: sleep
neuromodulation
academic performance
students
Lead sponsor: University of Las Palmas de Gran Canaria
Sponsor class: OTHER
Collaborators: name: Alfonso X El Sabio University
name: University of Alcala
name: University Pontifical of Salamanca
First posted: 2022-03-03
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial with passive control, triple blind (for the patient, the physiotherapist applying the technique and evaluator), with a parallel and multicenter design. The study will have two arms or groups; the intervention group (G1) will undergo neuromodulation treatment with the NESA XSIGNAL® device and the control group (G2) will not carry out any intervention, but both will be evaluated for the same variables at the same times.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Randomized clinical trial with passive control, triple-blind, with a parallel and multicenter design. The study will have two arms; the intervention group will have neuromodulation treatment with the NESA XSIGNAL® device and the control group will not carry out any intervention, but both will be evaluated for the same variables at the same times.

Multicenter study whose collaborating entities correspond to the University of Las Palmas de Gran Canaria, Alfonso X el Sabio University, the Pontifical University of Salamanca and the University of Alcalá de Henares. The study population will be students from the collaborating universities, corresponding to first-year health sciences degrees. For the selection of the sample, a non-probabilistic convenience sampling will be carried out, which allows selecting those accessible cases that agree to be included.

Patients who agree to participate will be randomly assigned to one of the 2 arms of the study (real device or control), using a fixed-size block design generated by the data manager to guarantee balanced randomization for each of the arms and in each of the participating universities. The assignment process will be carried out hidden and will be carried out by the support researcher in the Unit indicated for this study. Each research subject will be assigned an identification code corresponding to correlative numbers from 1 to 80, being from 1-20 subjects of the UPSA, from 21-40 students of the Alfonso X el Sabio University, from 41 to 60 students from the University of Las Palmas and from 61 to 80 from the University of Alcalá.

The intervention to which the subjects have been assigned, the specialist and the researcher who collects the information and carries out the follow-ups will be blinded. Data analysis will also be performed in a blinded fashion.

The default schedule is based on the goals set in this study. The main goal is to improve the quality of sleep. The secondary objectives are to correlate with improving the perception of stress and academic performance.

Eligibility criteria: 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.

Primary outcomes:
measure: Sleep quality
timeFrame: At the first consultation and through study completion, 5 weeks
measure: Salival Cortisol
timeFrame: At the first consultation and through study completion, 5 weeks
Secondary outcomes:
measure: Academic Stress
timeFrame: At the first consultation and through study completion, 5 weeks
measure: Coping with academic stress
timeFrame: At the first consultation and through study completion, 5 weeks
measure: Questionnaire of sociodemographic variables
timeFrame: At the first consultation and through study completion, 5 weeks
measure: ACADEMIC PERFORMANCE
timeFrame: Through study completion, 5 weeks
Other outcomes:
Locations:
city: Las Palmas De Gran Canaria
country: Spain
facility: Raquel Irina Medina Ramirez
state: Las Palmas
city: Madrid
country: Spain
facility: María Miana
Study officials:
affiliation: University of Las Palmas de Gran Canaria
name: Raque l I Medina Ramírez, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.