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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001385437
Enrollment
10
Registered
2025-12-11
Start date
2025-12-17
Completion date
2026-06-24
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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, 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 tra

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.

Sponsors

University of Las Palmas de Gran Canaria
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

• Professional female footballers aged 18–30 • Active during the study period • Participation in national or international competitions in past 2 years • No serious injury in previous 6 months • Written informed consent

Exclusion criteria

• Current serious injury • Participation in another clinical study in past 3 months • Medical contraindications • Contraindications to electrical stimulation • Medications interfering with outcomes that cannot be stopped

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 19, 2026