StressUSLEEPNCT05265494
Let´s Talk About Sleep in College Student
A study testing Non invasive neuromodulation NESA (XSIGNAL device) in people with Stress and Sleep Disturbance, run by University of Las Palmas de Gran Canaria at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress, Sleep Disturbance
- What is being tested?
- Non invasive neuromodulation NESA (XSIGNAL device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Nov 2021to 16 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Spain2 sites
Raquel Irina Medina Ramirez
Las Palmas de Gran Canaria, Las Palmas, 35018
María Miana
Madrid
About this study
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)
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.
Read the 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
- Being tested
- Non invasive neuromodulation NESA (XSIGNAL device)
- Keywords
- sleep, neuromodulation, academic performance, students
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: At the first consultation and through study completion, 5 weeks
Secondary outcomes (4)
Academic Stress
The questionnaire Academic Stress Questionnaire at University (Time Management Behavior Questionnaire for University Students, in english). It assesses possible stressful situations in the university environment and consists of a total of 21 items. The participants' responses indicate the level of perceived stress in each situation using a Likert-type response scale with 5 options ranging from "no stress" (1) to "a lot of stress" (5). .
The scale evaluates four complementary dimensions:
- Establishing objectives and priorities. Its response range lies between 10-50, and its internal consistency is .90.
- Time management tools. A response range between 11-55 and an internal consistency of .88.
- Preferences for disorganization. A response range between 8-40 and an internal consistency of .70.
- Perception of control over time. A response range between 5-25 and an internal consistency of .68
Measured: At the first consultation and through study completion, 5 weeks
Coping with academic stress
The Academic stress coping scale, known as A-CEA (Escala de afrontamiento del estrés académico, in spanish) (González Cabanach et al., 2010), is a subscale of the CEAU questionnaire. It evaluates the establishment of adequate time periods for studying (daily, weekly, monthly), the effective use of time, setting realistic objectives, and the characteristics of the setting in which the subject usually studies and does his or her academic activities. It consists of 8 items (e.g., "I make sure I am caught up on the material and projects"), with a response range between 8-56 and an internal consistency of .79.
Measured: At the first consultation and through study completion, 5 weeks
Questionnaire of sociodemographic variables
A third questionnaire to collect necessary information on sociodemographic variables such as age, gender, place of residence and type of home. This questionnaire also aims to collect some data regarding their academic life, such as the average grade for access to university and the degree completed. The ad-hoc questionnaire consists of a total of 11 items and all questions are made in a clear and concise manner so that the answer is free from ambiguity.
Measured: At the first consultation and through study completion, 5 weeks
ACADEMIC PERFORMANCE
The final average grade of the first academic semester will be analyzed comparing by groups.
Measured: Through study completion, 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start15 Nov 2021
- Primary completion16 Jan 2023
- Study completion16 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Las Palmas de Gran Canaria
- Sponsor type
- University, hospital or other
- Collaborators
- Alfonso X El Sabio University, University of Alcala, University Pontifical of Salamanca
- Responsible party
- Principal investigator, Daniel David Álamo Arce, University of Las Palmas de Gran Canaria
- Investigators
- Raque l I Medina Ramírez, PhD, Study director, University of Las Palmas de Gran Canaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265494
- Sponsor's protocol ID
- USLEEP
- Other IDs
- 001
- Acronym
- USLEEP
- Status last verified
- Jan 2023
- First submitted
- 5 Nov 2021
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be collected by computer in an encrypted Excel document (Microsoft Office Excel 2019 MSO 64-bit program). Everything is collected in accordance with the provisions of Organic Law 3/2018, of December 5, on the Protection of Personal Data and guarantee of digital rights and by virtue of the provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council, of April 27, 2016, regarding the protection of natural persons with regard to the processing of personal data and the free circulation of these data.
Publications
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.
PubMed 20864434Escobar-Cordoba F, Eslava-Schmalbach J. [Colombian validation of the Pittsburgh Sleep Quality Index]. Rev Neurol. 2005 Feb 1-15;40(3):150-5. Spanish.
PubMed 15750899
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05265494
- Acronym / sponsor ID
- USLEEP / USLEEP
- Conditions
- Stress, Sleep Disturbance
- Keywords
- sleep, neuromodulation, academic performance, students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Las Palmas de Gran CanariaUniversity, hospital or other
- Collaborators
- Alfonso X El Sabio University, University of Alcala, University Pontifical of Salamanca
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 16 Jan 2023 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| NESA INTERVENTION | Experimental | Device: Non invasive neuromodulation NESA (XSIGNAL device)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). |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Device | NESA INTERVENTION |
Primary outcome
Sleep quality
Time frame: At the first consultation and through study completion, 5 weeks
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.
Salival Cortisol
Time frame: At the first consultation and through study completion, 5 weeks
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
4 secondary outcomes
Academic Stress
Time frame: At the first consultation and through study completion, 5 weeks
Coping with academic stress
Time frame: At the first consultation and through study completion, 5 weeks
Questionnaire of sociodemographic variables
Time frame: At the first consultation and through study completion, 5 weeks
ACADEMIC PERFORMANCE
Time frame: Through study completion, 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Background: PubMed 20864434Gaultney 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.
- Background: PubMed 15750899Escobar-Cordoba F, Eslava-Schmalbach J. [Colombian validation of the Pittsburgh Sleep Quality Index]. Rev Neurol. 2005 Feb 1-15;40(3):150-5. Spanish.
- Individual participant dataSharing planned: No. All data will be collected by computer in an encrypted Excel document (Microsoft Office Excel 2019 MSO 64-bit program). Everything is collected in accordance with the provisions of Organic Law 3/2018, of December 5, on the Protection of Personal Data and guarantee of digital rights and by virtue of the provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council, of April 27, 2016, regarding the protection of natural persons with regard to the processing of personal data and the free circulation of these data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raque l I Medina Ramírez, PhD study director
University of Las Palmas de Gran Canaria
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non invasive neuromodulation NESA (XSIGNAL device) in people with Stress and Sleep Disturbance, run by University of Las Palmas de Gran Canaria at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (time frame: At the first consultation and through study completion, 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05265494, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.