Let´s Talk About Sleep in College Student (USLEEP)

University of Las Palmas de Gran Canaria

Status: Completed

Conditions: Sleep Disturbance; Stress

Treatments: Device: Non invasive neuromodulation NESA (XSIGNAL device)

Study type: Interventional

Funder types: Other

Identifiers

NCT05265494

USLEEP

001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

NESA INTERVENTION

Experimental group

Description:

Group 1: Application of Nesa microcurrents through the NXSIGNAL® generator twice a week. The study volunteers are treated with the NXSIGNAL® device in sessions of 60 minutes, twice a week and for 5 weeks (10 sessions).

Treatment:

Device: Non invasive neuromodulation NESA (XSIGNAL device)

CONTROL-NO INTERVENTION

No Intervention group

Description:

Group 2: Control group without NESA XSIGNAL® application The same protocol for the analysis of variables is followed, but without performing any type of treatment with the NESA XSIGNAL device.