Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001385437
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
15/10/2025
Date registered
Help: Date registered
11/12/2025
Date last updated
Help: Date last updated
12/02/2026
Date data sharing statement initially provided
Help: Data sharing statement date
11/12/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of non-invasive neuromodulation on sleep quality and recovery in elite female football players
Scientific title
Effects of Applied Superficial Electrical Neuromodulation (NESA) on sleep quality and recovery in elite female athletes: a randomized controlled pilot trial
Additional trial identifiers [1] 315589 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Poor sleep quality 339231 0
neuromuscular recovery/fatigue in elite female athletes 339232 0
Condition category
Condition code
Musculoskeletal 335506 335506 0 0
Normal musculoskeletal and cartilage development and function
Physical Medicine / Rehabilitation 335507 335507 0 0
Physiotherapy
Neurological 335864 335864 0 0
Studies of the normal brain and nervous system
Mental Health 335865 335865 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
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.
Intervention code [1] 332211 0
Treatment: Devices
Description of the comparator or control
The control group follows the team’s standard in-season program, including routine football training sessions (technical–tactical and conditioning), strength and conditioning as scheduled by staff, standard recovery procedures (cool-down, mobility, hydration/nutrition guidance, sleep hygiene education), and access to usual medical/physiotherapy care as needed. No neuromodulation or microcurrent devices are used in the control condition.
Both groups complete all scheduled testing and monitoring procedures.
Control group
Active

Outcomes
Primary outcome [1] 343059 0
Sleep quality
Timepoint [1] 343059 0
Baseline and 8 weeks following end of treatment
Primary outcome [2] 343060 0
Autonomic recovery
Timepoint [2] 343060 0
Baseline and 8 weeks following end of treatment
Secondary outcome [1] 453290 0
Salivary cortisol
Timepoint [1] 453290 0
Baseline and 8 weeks following end of treatment
Secondary outcome [2] 453291 0
Neuromuscular state
Timepoint [2] 453291 0
Baseline and 8 weeks following end of treatment
Secondary outcome [3] 453292 0
Competitive anxiety
Timepoint [3] 453292 0
Baseline and 8 weeks following end of treatment
Secondary outcome [4] 453293 0
Menstrual-related quality of life
Timepoint [4] 453293 0
Baseline and 8 weeks following end of treatment
Secondary outcome [5] 454306 0
Neuromuscular state
Timepoint [5] 454306 0
Baseline and 8 weeks following end of treatment
Secondary outcome [6] 454307 0
Neuromuscular State
Timepoint [6] 454307 0
Baseline and 8 weeks following end of treatment

Eligibility
Key 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
Minimum age
18 Years
Maximum age
30 Years
Sex
Females
Healthy volunteers
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation with 1:1 allocation using permuted blocks of variable size (e.g., 4 and 6) to maintain balance across groups in a small pilot sample. Allocation sequence generated by an independent researcher; assignments implemented with coded IDs and sequentially numbered, opaque, sealed envelopes (allocation concealment)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All data will be analysed using SPSS and R software. Within- and between-group comparisons across timepoints. Descriptive statistics, repeated-measures ANOVA, and effect sizes (Cohen’s d) will be reported.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/12/2025
Actual
17/12/2025
Date of last participant enrolment
Anticipated
24/06/2026
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
20
Accrual to date
10
Final
Recruitment outside Australia
Country [1] 27444 0
Spain
State/province [1] 27444 0

Funding & Sponsors
Funding source category [1] 320189 0
Self funded/Unfunded
Name [1] 320189 0
Country [1] 320189 0
Primary sponsor type
University
Name
University of Las Palmas de Gran Canaria
Address
Country
Spain
Secondary sponsor category [1] 322751 0
None
Name [1] 322751 0
Address [1] 322751 0
Country [1] 322751 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318729 0
Research Ethics Committee/Committee of Ethics of Drug Research (CEI/CEIm) of Las Palmas
Ethics committee address [1] 318729 0
Ethics committee country [1] 318729 0
Spain
Date submitted for ethics approval [1] 318729 0
17/06/2024
Approval date [1] 318729 0
01/10/2025
Ethics approval number [1] 318729 0
CEIm: 2024-281-1

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 145082 0
Miss Marlene García Quintana
Address 145082 0
University of Las Palmas de Gran Canaria – Faculty of Health Sciences, P.º Blas Cabrera Felipe “Físico”, s/n, 35016 Las Palmas de Gran Canaria, Las Palmas, Spain.
Country 145082 0
Spain
Phone 145082 0
+34 928451860
Fax 145082 0
Email 145082 0
[email protected]
Contact person for public queries
Name 145083 0
Marlene García Quintana
Address 145083 0
University of Las Palmas de Gran Canaria – Faculty of Health Sciences, P.º Blas Cabrera Felipe “Físico”, s/n, 35016 Las Palmas de Gran Canaria, Las Palmas, Spain.
Country 145083 0
Spain
Phone 145083 0
+34 928451860
Fax 145083 0
Email 145083 0
[email protected]
Contact person for scientific queries
Name 145084 0
Marlene García Quintana
Address 145084 0
University of Las Palmas de Gran Canaria – Faculty of Health Sciences, P.º Blas Cabrera Felipe “Físico”, s/n, 35016 Las Palmas de Gran Canaria, Las Palmas, Spain.
Country 145084 0
Spain
Phone 145084 0
+34 928451860
Fax 145084 0
Email 145084 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.