Let´s Talk About Sleep in College Student

NCT05265494 | Completed DMC

• 2 other identifiers: USLEEP001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Stress; Sleep Disturbance

Keywords

sleep; neuromodulation; academic performance; students

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Academic Stress

  At the first consultation and through study completion, 5 weeks

• Coping with academic stress

  At the first consultation and through study completion, 5 weeks

• Questionnaire of sociodemographic variables

  At the first consultation and through study completion, 5 weeks

• ACADEMIC PERFORMANCE

  Through study completion, 5 weeks

Study Arms (2)

NESA INTERVENTION

EXPERIMENTAL

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).

Device: Non invasive neuromodulation NESA (XSIGNAL device)

CONTROL-NO INTERVENTION

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.

Interventions

Non invasive neuromodulation NESA (XSIGNAL device) 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)

NESA INTERVENTION

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Las Palmas de Gran Canaria: lead
• Alfonso X El Sabio University: collaborator
• University of Alcala: collaborator
• University Pontifical of Salamanca: collaborator

Study Sites (2)

Raquel Irina Medina Ramirez

Las Palmas de Gran Canaria, Las Palmas, 35018, Spain

Location

María Miana

Madrid, Spain

Location

Related Publications (2)

• 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.

  PMID: 20864434 BACKGROUND

• 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.

  PMID: 15750899 BACKGROUND

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Raque l I Medina Ramírez, PhD

  University of Las Palmas de Gran Canaria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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 way.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: March 3, 2022
• Study Start: November 15, 2021
• Primary Completion: January 16, 2023
• Study Completion: January 16, 2023
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)