Effects of BEMER Electromagnetic Field Intervention on Sleep, Readiness to Play and Injuries in Elite Athletes

NCT ID: NCT07299669

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-18

Study Completion Date

2025-10-15

Brief Summary

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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.

Detailed Description

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Contrary to common assumptions, athletes often experience insufficient sleep, particularly in the context of competitive events. Furthermore, a significant proportion of athletes report poor sleep quality, potentially linked to frequent travel, intense training, suboptimal training times and inadequate caloric intake. Female athletes are especially susceptible, facing additional challenges such as role conflicts, gender discrimination, body image concerns, increased risk of eating disturbances, and negative impact from menstruation, all of which may hinder restitution. A promising intervention to enhance and facilitate restitution involves the use of low frequency pulsed electromagnetic field (PEMF) therapy, which has demonstrated the potential to increase blood flow, particularly in micro vessels, and is as such assumed to increase micro-circulation, among other in the skeleton muscles. The effectiveness of PEMF therapy in athletes has so far not been investigated using a randomized controlled design.

In this study, a triple blind (participants, researchers and statistician) randomized controlled trial will be undertaken, with female athletes (N=60) from national (Norway) football teams being randomly designed to receive either a placebo mattress or a PEMF-mattress based on a 1:1 ratio, using stratified randomization by team. During a baseline assessment period of 4 weeks, 3 primary outcomes (radar assessed total sleep time and sleep efficiency), and readiness to play (composite measure of daily self-report of fatigue, sleep quality, muscle soreness, stress and mood) will be recorded at a daily basis. These 3 outcomes will be analyzed also specifically for the day/night following matches (as secondary outcomes). Other secondary outcomes comprise the amount (duration) of slow wave sleep/deep, assessed with the sleep radar technology, the severity of injuries, and the rate of perceived exertion (RPE) following training and matches.

The participants (N=60) will following the 4-week baseline registration commence a 10 week intervention phase involving daily use of the mattress for 2 (morning and evening) x 8 minutes. The system has 3 levels of PEMF-intensity (low, medium, high). The first four weeks the low intensity will be used, the next two the medium intensity will be used, thereafter (last four weeks) the high intensity will be used. This intervention period will be accompanied by reassessment of the primary and secondary outcomes during the last 4 weeks of the 10-week intervention period.

Conditions

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Fatigue Recovery

Keywords

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BEMER Athletes Recovery Sleep Injury Readiness to play Rate of perceived exertion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The two arms/conditions involves an electromagnetic mattress and an sham-mattress
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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BEMER electromagnetic-energy-regulation therapy

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

Group Type EXPERIMENTAL

BEMER electromagnetic-energy-regulation therapy

Intervention Type DEVICE

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

Sham-mattress

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

Group Type SHAM_COMPARATOR

Sham (No Treatment)

Intervention Type DEVICE

Sham mattress with no electromagnetic output

Interventions

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BEMER electromagnetic-energy-regulation therapy

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

Intervention Type DEVICE

Sham (No Treatment)

Sham mattress with no electromagnetic output

Intervention Type DEVICE

Other Intervention Names

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BEMER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

• None
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Western Norway University of Applied Sciences

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

University of Bergen

OTHER

Sponsor Role lead

Responsible Party

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Ståle Pallesen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ståle Pallesen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Locations

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Bergensregionen

Bergen, , Norway

Site Status

Osloregionen

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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BeSCN 25/1

Identifier Type: -

Identifier Source: org_study_id