NCT05265494

Let´s Talk About Sleep in College Student

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Las Palmas de Gran Canaria · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Stress
• Sleep Disturbance

Interventions

Type	Name	Description
DEVICE	Non invasive neuromodulation NESA (XSIGNAL device)	The study volunteers are treated with the NXSIGNAL® device in sessions of 60 minutes, twice a week and for 5 weeks (10 sessions). • The skin must be clean, free of creams and grease, lectrodes are connected to the control console and the targeting electrode located in over the intervertebral area between C7 and T1 (cervical area) and will follow the central treatment pattern with the following combination: * 2 sessions: Program 1 (30 min), Program 7 (15min) and Program 8 (15min). * 4 sessions: Program 2 (15min), Program 7 (30 min) and Program 8 (15min) * 4 sessions: Program 7 (60min)

Timeline

• Start date: 2021-11-15
• Primary completion: 2023-01-16
• Completion: 2023-01-16
• First posted: 2022-03-03
• Last updated: 2023-01-18

Locations

2 sites across 1 country: Spain