RecruitingACTRN12625001385437

Effects of non-invasive neuromodulation on sleep quality and recovery in elite female football players

Effects of Applied Superficial Electrical Neuromodulation (NESA) on sleep quality and recovery in elite female athletes: a randomized controlled pilot trial


Sponsor

University of Las Palmas de Gran Canaria

Enrollment

20 participants

Start Date

Dec 17, 2025

Study Type

Interventional

Conditions

Summary

This study aims to examine whether a non-invasive neuromodulation technique can improve sleep quality and recovery in elite female football players. The intervention uses the NESA® XSIGNAL® microcurrent system, which delivers very low-intensity electrical impulses through electrodes placed on the hands, feet, and a small number of additional body sites. The treatment is completely painless and aims to stimulate the autonomic nervous system to promote better sleep and physiological recovery after training and competition. Twelve professional female football players will be randomly assigned to either an intervention group, receiving the NESA® neuromodulation sessions, or a control group, continuing their usual training without the device. The treatment lasts eight weeks (four sessions per week, 60 minutes each). The researchers will assess sleep quality (using the Pittsburgh Sleep Quality Index), heart rate variability (a marker of autonomic balance), neuromuscular performance (sprint and jump tests), hormonal markers (salivary cortisol), and perceived anxiety before and after the intervention. The results may provide valuable information on whether this non-invasive and safe technology can be used to support recovery and performance in elite female athletes, contributing to evidence-based physiotherapy and sports medicine practices.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 30 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a gentle, painless electrical treatment can help elite female football players sleep better and recover faster from training and games. The treatment uses a device called NESA XSIGNAL, which sends tiny electrical impulses through electrodes placed on the hands and feet. These micro-currents are designed to calm the nervous system in a way that supports deeper sleep and better physical recovery. Twelve professional female footballers will take part over eight weeks, with half receiving the treatment four times a week and the other half continuing their normal training routine without it. Researchers will measure sleep quality, heart rate patterns, speed, jump ability, stress hormone levels, and anxiety before and after the program. You may be eligible if you are a female professional footballer aged 18 to 30, currently competing at a national or international level, and have not had a serious injury in the past six months. This is a small study looking to find out whether this type of non-invasive technology is safe and helpful for athlete recovery.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

articipants allocated to the intervention will receive non-invasive microcurrent neuromodulation using the NESA device system. Standardized surface electrodes are placed on both hands and both feet, p

articipants allocated to the intervention will receive non-invasive microcurrent neuromodulation using the NESA device system. Standardized surface electrodes are placed on both hands and both feet, plus one directing electrode that varies by phase (see below). Sessions are delivered four times per week, 60 minutes each, for 8 weeks (32 sessions total). Intensity: device “Low” setting (microcurrent; not perceptible to participants). Frequencies: within 1–15 Hz, delivered as bioelectric pulse trains (up to ~19,000 pulses/min); frequency may be fixed or variable within this range by program. Provider: Licensed physiotherapists trained in the clinical use of the NESA system and not involved in outcome assessment. Five progressive phases (program order and durations within each 60-min session): - Phase 1 (Week 1; acclimation; directing electrode at C6–C7): P1: 15 min. P2: 15 min. P7: 15 min. P8: 15 min. - Phase 2 (Week 2; circadian/sleep focus; directing electrode frontal midline): P2: 20 min. P4: 20 min. P5: 20 min. - Phase 3 (Weeks 3–4; autonomic regulation; directing electrode at C6–C7): P7: 40 min. P8: 20 min. - Phase 4 (Weeks 5–7; performance/recovery; directing electrode at C6–C7): P2: 15 min. P7: 30 min. P8: 15 min. - Phase 5 (Week 8; consolidation; directing electrode at C6–C7): P7: 45 min. P8: 15 min. Programs used and how they differ (as per protocol): - Program 1 (P1): Alternating stimulus times with frequencies ~3.85–7.69 Hz, sequential delivery across the 24 electrodes, multiple pauses, alternating polarity. - Program 2 (P2): Frequencies ~1.14–1.96 Hz with input pathways emphasising distal channels of upper/lower limbs; sequencing oriented ventrally. - Program 4 (P4): Preset pattern with lower-frequency ranges and sustained cycles to support sleep-related scheduling (used in circadian phase). - Program 5 (P5): Preset pattern with progressive sequencing/duty cycle adjustments (used in circadian phase). - Program 7 (P7): Alternating stimulus times with frequencies ~1.92–14.29 Hz, symmetric positive/negative pulses; multi-channel sequencing. - Program 8 (P8): Sequential stimuli with stable frequency ~7.69 Hz, symmetric polarity across channels. Adherence/fidelity monitoring: - Attendance logs for each session (start/stop times). - Electrode placement checklist (location, integrity, skin preparation). - Session record of program(s), order, and exact programmed durations. - Random internal audits of =10% of sessions by a senior investigator. - Documentation of any protocol deviations.


Locations(1)

Spain

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ACTRN12625001385437