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Impact of a multisession LPG cellu M6 alliance program: effects on sleep quality, immune function, and stress levels in stressed individuals

NCT ID NCT07811284

NEW Sponsor: Bescored Source: ClinicalTrials.gov ↗

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 10, 2026

Summary

This bicentric, randomized, single-blind clinical investigation aims to evaluate the effects of a multisession mechanical massage (endermologie) program on sleep quality, immune function, and stress levels in individuals experiencing high levels of stress. The investigational device is the LPG Cellu M6 Alliance (LPG Systems), a CE-marked Class IIa medical device. Endermologie is a non-invasive mechanical stimulation technique that uses motorized rollers and flaps to mobilize the skin and underlying tissues. All treatment sessions will be performed by a trained therapist. Participants will be randomly assigned to either an experimental group or a sham control group and will undergo 10 sessions of endermologie, with or without mechanical massage, respectively. Sleep quality, psychological status, cognitive performance, heart rate variability, perceived well-being, muscle and joint pain, immune-related parameters, and body composition will be assessed throughout the study. Sleep will be monitored during the experimental period using an actigraph and a sleep diary.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

32 people

The number who actually took part.

Started

Jan 2023

Finished

Jun 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Score \>7 on the Insomnia Severity Index (ISI) questionnaire; * Score \>13 on the Perceived Stress Scale (PSS) questionnaire; * Weekly physical activity level below the level recommended by the World Health Organization (WHO), i.e., less than 300 minutes of moderate-intensity physical activity or less than 150 minutes of vigorous-intensity physical activity per week. Exclusion Criteria: * Vulnerable persons as defined in Articles L.1121-5 to L.1121-8 and L.1122-1-2 of the French Public Health Code (e.g., persons deprived of liberty, minors, or adults under legal protection); * Medical contraindication to endermologie treatment (see list of contraindications below); * Previous endermologie treatment session; * Current medication that may alter gut microbiota function, including antibiotics, corticosteroids, antidepressants, anxiolytics, antidiabetic medications, or antiasthmatic medications; * Absence of informed consent; * Refusal to cooperate; * Contraindication to an LPG endermologie treatment session.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stress (psychology)

Contacts and locations

Locations

  • beScored Institute

    Valbonne, France, 06560, France

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