NCT07299669

Brief Summary

Elite athletes (female football players) will be randomized to 1 of 2 conditions, comprising a BEMER electromagnet field mattress and a sham-mattress. The mattress is to be used in bed for 8 minutes each morning, and for 8 minutes each evening, for 10 weeks. The system has 3 intensity levels - low, medium, and high. The low level will be used for the 4 first weeks, the medium level for the following 2 weeks, and the high level for the last 4 weeks. Those in the sham conditions have a display and mattress looking identical, and follow the same procedure as those in BEMER electromagnet field mattress condition. The primary outcome comprises total sleep time and sleep efficacy assessed with a sleep radar as well as readiness to play (composite measure of daily self-report of fatigue, sleep quality, muscle soreness, stress and mood). Secondary outcomes comprise duration of deep sleep also assessed with the sleep radar, injury severity, and rate of perceived exertion following training and matches. Baseline registrations are conducted for 4 weeks prior to the intervention and outcomes are registered during the last 4 weeks of the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 26, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 23, 2025

Completed
Last Updated

January 6, 2026

Status Verified

November 1, 2025

Enrollment Period

9 months

First QC Date

November 26, 2025

Last Update Submit

December 30, 2025

Conditions

Keywords

BEMERAthletesRecoverySleepInjuryReadiness to playRate of perceived exertion

Outcome Measures

Primary Outcomes (3)

  • Total sleep time

    Total sleep time in the main sleep episode assessed with the sleep radar Somnofy, expressed as minutes per day. High total sleep time is regarded as a more positive outcome than a lower total sleep time.

    Change from baseline (4 weeks before interventions) to the last 4 weeks of the intervention.

  • Sleep efficiency

    Percentage of time in bed following shut-eye (lights out) to rising from bed where the participant did sleep - assessed with the sleep radar Somnofy during the main sleep period. The measure comprises the percentage of time being asleep, and higher values (percentage) are regarded as a better outcome than lower values (percentage).

    Change from baseline (4 weeks before intervention) to the last 4 weeks of the intervention

  • Readiness to play

    Daily morning self-report on an adapted version of the Hooper Index (Hooper, Mackinnon, Howard, Gordon, \& Bachmann, 1995), comprising four items assessing fatigue, sleep quality, muscle soreness, and stress. Each item is rated on a 7-point scale ranging from 1 to 7 (where 7 is the worst state and 1 is the best state). A composite daily score ranging from 4 to 28 is calculated - lower scores are associated with the best outcomes.

    Change from baseline (4 weeks before intervention) to the last 4 weeks of the intervention

Secondary Outcomes (6)

  • Total sleep time the day following matches

    Change from baseline (4 weeks before interventions) to the last 4 weeks of the intervention exclusively on the nights after matches.

  • Sleep efficiency the day following matches

    Change from baseline (4 weeks before intervention) to the last 4 weeks of the intervention exclusively the night following matches.

  • Readiness to play the day after matches

    Change from baseline (4 weeks before intervention) to the last 4 weeks of the intervention, exclusively on the day after matches.

  • Deep sleep duration

    Change from baseline (4 weeks before intervention) to the last 4 weeks of the intervention

  • Health problems

    Change from baseline (4 weeks before interventions) to the last 4 weeks of the intervention.

  • +1 more secondary outcomes

Study Arms (2)

BEMER electromagnetic-energy-regulation therapy

EXPERIMENTAL

BEMER electromagnetic mattress; week 1-4 at low lever, week 5-6 medium level and week 7-10 high level

Device: BEMER electromagnetic-energy-regulation therapy

Sham-mattress

SHAM COMPARATOR

Mattress and interface panel similar to the experimental intervention, but without any electromagnetic output signals

Device: Sham (No Treatment)

Interventions

The BEMER is bio-electric-magnetics-energy-regulation therapy uses a specific waveform of pulsed electromagnetic field (PEMF) to improve microcirculation by 30%. In the present study the bio-electric-magnetics-energy-regulation therapy will be provided through mattresses

Also known as: BEMER
BEMER electromagnetic-energy-regulation therapy

Sham mattress with no electromagnetic output

Sham-mattress

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Minimum 18 years of age
  • Female elite football player in Norway
  • Playing on team willing to part-take in the study

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bergensregionen

Bergen, Norway

Location

Osloregionen

Oslo, Norway

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Ståle Pallesen, PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: The two arms/conditions involves an electromagnetic mattress and an sham-mattress
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 26, 2025

First Posted

December 23, 2025

Study Start

January 18, 2025

Primary Completion

October 15, 2025

Study Completion

October 15, 2025

Last Updated

January 6, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Complete dataset

Shared Documents
STUDY PROTOCOL
Time Frame
From January 1, 2027
Access Criteria
Researchers with a phd and relevant background can access the material. In order to get the material they need to contact the PI. They will be provided with the study protocol

Locations