Let´s Talk About Sleep in College Student

NCT ID: NCT05265494

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2023-01-16

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.

Conditions

Stress; Sleep Disturbance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

NESA INTERVENTION

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).

Group Type: EXPERIMENTAL

Non invasive neuromodulation NESA (XSIGNAL device)

Intervention Type: 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)

CONTROL-NO INTERVENTION

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: DEVICE

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alfonso X El Sabio University

OTHER

Sponsor Role: collaborator

University of Alcala

OTHER

Sponsor Role: collaborator

University Pontifical of Salamanca

UNKNOWN

Sponsor Role: collaborator

University of Las Palmas de Gran Canaria

OTHER

Sponsor Role: lead

Responsible Party

Daniel David Álamo Arce

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raque l I Medina Ramírez, PhD

Role: STUDY_DIRECTOR

University of Las Palmas de Gran Canaria

Locations

Raquel Irina Medina Ramirez

Las Palmas de Gran Canaria, Las Palmas, Spain

María Miana

Madrid, , Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 20864434 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15750899 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

001

Identifier Type: OTHER

Identifier Source: secondary_id

USLEEP

Identifier Type: -

Identifier Source: org_study_id