Stress (Psychology)NCT07811284

Effects of Mechanical Massage on Sleep Quality, Immunity, and Stress

A study testing Mechanized Massage (LPG Cellu M6 Alliance) in people with Stress (Psychology), run by Bescored at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Stress (Psychology)
What is being tested?: Mechanized Massage (LPG Cellu M6 Alliance)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteFrance
Study dates: 12 Jan 2023to 14 Jun 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

France1 site

beScored Institute
Valbonne, France, 06560

Other trials in France

About this study

Official title: Impact of a Multisession LPG Cellu M6 Alliance Program: Effects on Sleep Quality, Immune Function, and Stress Levels in Stressed Individuals

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.

Conditions: Stress (Psychology)
Being tested: Mechanized Massage (LPG Cellu M6 Alliance), Sham Mechanized Massage (LPG Cellu M6 Alliance)
Keywords: Massage intervention, Endermology, Stress, Sleep

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mechanized Massage (LPG Cellu M6 Alliance)Device
Mechanized massage using the LPG Cellu M6 Alliance® device (LPG Systems, Valence, France), a CE-marked Class IIa medical device. The intervention consists of 10 sessions of 40 minutes each, performed over a 5-week period. Treatment is delivered by a trained operator using a motorized treatment head with adjustable flaps, rollers, and suction.
Sham Mechanized Massage (LPG Cellu M6 Alliance)Device
Sham treatment using the LPG Cellu M6 Alliance device with minimal mechanical parameters. The sham intervention follows the same treatment schedule, duration, body positioning, anatomical regions, and operator procedures as the experimental intervention, while minimizing mechanical tissue mobilization.

Study groups in NCT07811284
Study group	Role	What they receive
Experimental group (G-EXP)	Experimental	Participants assigned to the experimental group will receive ten 40-minute mechanized massage sessions over five weeks using the CE-marked LPG Cellu M6 Alliance® device. The device delivers mechanized skin mobilization through a treatment head equipped with motorized flaps, adjustable suction, and rollers. All sessions will be performed by the same trained operator. Each 40-minute session will consist of 10 minutes in the supine position targeting the anterior body, followed by 30 minutes in the prone position targeting the posterior body. Treatment parameters will be adapted to the anatomical regions treated, including the dorsum, neck, sacrum, lower limbs, feet, sternum, abdomen, and thighs. Receives: Device: Mechanized Massage (LPG Cellu M6 Alliance)
Sham-control group (G-CONT)	Sham comparator	Participants assigned to the sham-control group will receive ten 40-minute sham mechanized massage sessions over five weeks using the CE-marked LPG Cellu M6 Alliance® device. The sessions will follow the same treatment schedule, duration, anatomical regions, participant positioning, and operator procedures as those used in the experimental group. The device will be operated using minimal mechanical parameters (Power: 0; Frequency: 0; Duty cycle: 0; Flap: 1.0; Roll speed: 100; Suction: 100%), designed to minimize mechanical tissue mobilization while maintaining the treatment procedure and device contact. All sessions will be performed by the same operator. Receives: Device: Sham Mechanized Massage (LPG Cellu M6 Alliance)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline in Sleep Efficiency at End of Intervention
Sleep efficiency will be objectively assessed using wrist actigraphy (MotionWatch 8, Cambridge Neurotechnology Ltd., UK), worn on the non-dominant wrist during the night. Data will be sampled at 50 Hz and processed in 30-second epochs using MotionWare software (version 1.2.5). Sleep efficiency will be calculated as the percentage of time spent asleep relative to time in bed. Actigraphy-derived sleep efficiency will be averaged over 4 consecutive nights at four assessment time points: Baseline (pre-program), Early (after Session 1), Mid (after Session 5), and End (after Session 10). The primary outcome will be the change in mean sleep efficiency from baseline to the end of the intervention.
Unit of Measure: Percentage (%) Scale: 0% to 100%; higher values will indicate greater sleep efficiency.
Measured: Baseline and at 4 weeks
Change from Baseline in Sleep Fragmentation at End of Intervention
Sleep fragmentation will be objectively assessed using wrist actigraphy (MotionWatch 8, Cambridge Neurotechnology Ltd., UK), worn on the non-dominant wrist during the night. Data will be sampled at 50 Hz and processed in 30-second epochs using MotionWare software (version 1.2.5). Sleep fragmentation will be quantified using the actigraphy-derived fragmentation index, an activity-based measure reflecting the degree of sleep restlessness and fragmentation based on movement frequency and immobility phases during the sleep period. The fragmentation index will be averaged over 4 consecutive nights at four assessment time points: Baseline (pre-program), Early (after Session 1), Mid (after Session 5), and End (after Session 10). The primary outcome will be the change in mean sleep fragmentation from baseline to the end of the intervention.
Unit of Measure: arbitrary units (a.u.); higher values will indicate greater sleep fragmentation.
Measured: Baseline and at 4 weeks
Change from Baseline in Salivary Cortisol Concentration at End of Intervention
Objective stress will be assessed using salivary cortisol following standardized procedures. To minimize the influence of external factors on cortisol concentrations, participants will be instructed to follow standardized pre-assessment procedures. Circadian variation will be controlled by requiring participants to wake up at least three hours before testing, with all assessments scheduled after 11:30 a.m. Session 1 and Session 10 assessments will be scheduled at the same time of day for each participant to ensure comparable cortisol measurements across the intervention period. Cortisol concentrations will be determined using a validated salivary cortisol enzyme-linked immunosorbent assay (ELISA) protocol. The change in salivary cortisol concentration from baseline to the end of the intervention will be assessed.
Unit of Measure: nmol/L higher cortisol concentrations will indicate higher physiological stress levels.
Measured: Baseline and a 4 weeks

Secondary outcomes (4)

Change from Baseline in Insomnia Severity Index Score at End of Intervention
Insomnia symptoms will be assessed using the Insomnia Severity Index (ISI), a validated 7-item questionnaire designed to assess the severity of insomnia symptoms. The total score will be calculated according to the validated scoring procedure. The change in ISI score from baseline to the end of the intervention will be assessed.
Unit of Measure: Score Scale: 0 to 28; higher scores will indicate greater severity of insomnia symptoms.
Measured: Baseline and a 4 weeks
Change from Baseline in Sleep Quality at End of Intervention
Perceived sleep quality will be assessed using the 6-item Spiegel Sleep Questionnaire (SSQ). The total score will be calculated according to the validated scoring procedure. The change in SSQ score from baseline to the end of the intervention will be assessed.
Unit of Measure: Score Scale: 0 to 30; higher scores will indicate better perceived sleep quality
Measured: Baseline and at 4 weeks
Change from Baseline in Sleep Reactivity at End of Intervention
Sleep reactivity will be assessed using the Ford Insomnia Response to Stress Test (FIRST), a validated questionnaire designed to assess an individual's predisposition to sleep disturbance in response to stressful situations. The total score will be calculated according to the validated scoring procedure. The change in FIRST score from baseline to the end of the intervention will be assessed.
Unit of Measure: Score Scale: 9 to 36; higher scores will indicate greater sleep reactivity.
Measured: Baseline and at 4 weeks
Change from Baseline in Perceived Stress at End of Intervention
Perceived stress will be assessed using the Perceived Stress Scale (PSS). The total score will be calculated according to the validated scoring procedure. The change in PSS score from baseline to the end of the intervention will be assessed.
Unit of Measure: Score Scale: 0 to 40; higher scores will indicate greater perceived stress.
Measured: Baseline and at 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jan 202314 Jun 2023

First posted10 Sep 2026
Study start12 Jan 2023
Primary completion14 Jun 2023
Study completion14 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stress (Psychology)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07811284
Sponsor's protocol ID: 2022-A01741-42
Status last verified: Sep 2026
First submitted: 1 Sep 2026
Last updated: 10 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: A decision regarding the sharing of individual participant data has not yet been made. Any future data sharing will be considered in accordance with applicable ethical, legal, and data protection requirements

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of a Multisession LPG Cellu M6 Alliance Program: Effects on Sleep Quality, Immune Function, and Stress Levels in Stressed Individuals
ClinicalTrials.gov ID: NCT07811284
Acronym / sponsor ID: 2022-A01741-42
Conditions: Stress (Psychology)
Keywords: Massage intervention, Endermology, Stress, Sleep
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: BescoredUniversity, hospital or other
Collaborators: centre du sommeil et de la vigilance, APHP, European Sleep Center
Study start: 12 Jan 2023 (actual)
Primary completion: 14 Jun 2023 (actual)
Study completion: 14 Jun 2023 (actual)
First posted: 10 Sep 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Experimental group (G-EXP)	Experimental	Device: Mechanized Massage (LPG Cellu M6 Alliance)Participants assigned to the experimental group will receive ten 40-minute mechanized massage sessions over five weeks using the CE-marked LPG Cellu M6 Alliance® device. The device delivers mechanized skin mobilization through a treatment head equipped with motorized flaps, adjustable suction, and rollers. All sessions will be performed by the same trained operator. Each 40-minute session will consist of 10 minutes in the supine position targeting the anterior body, followed by 30 minutes in the prone position targeting the posterior body. Treatment parameters will be adapted to the anatomical regions treated, including the dorsum, neck, sacrum, lower limbs, feet, sternum, abdomen, and thighs.
Sham-control group (G-CONT)	Sham comparator	Device: Sham Mechanized Massage (LPG Cellu M6 Alliance)Participants assigned to the sham-control group will receive ten 40-minute sham mechanized massage sessions over five weeks using the CE-marked LPG Cellu M6 Alliance® device. The sessions will follow the same treatment schedule, duration, anatomical regions, participant positioning, and operator procedures as those used in the experimental group. The device will be operated using minimal mechanical parameters (Power: 0; Frequency: 0; Duty cycle: 0; Flap: 1.0; Roll speed: 100; Suction: 100%), designed to minimize mechanical tissue mobilization while maintaining the treatment procedure and device contact. All sessions will be performed by the same operator.

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mechanized Massage (LPG Cellu M6 Alliance)Mechanized massage using the LPG Cellu M6 Alliance® device (LPG Systems, Valence, France), a CE-marked Class IIa medical device. The intervention consists of 10 sessions of 40 minutes each, performed over a 5-week period. Treatment is delivered by a trained operator using a motorized treatment head with adjustable flaps, rollers, and suction.	Device	Experimental group (G-EXP)
Sham Mechanized Massage (LPG Cellu M6 Alliance)Sham treatment using the LPG Cellu M6 Alliance device with minimal mechanical parameters. The sham intervention follows the same treatment schedule, duration, body positioning, anatomical regions, and operator procedures as the experimental intervention, while minimizing mechanical tissue mobilization.	Device	Sham-control group (G-CONT)

Primary outcome

Change from Baseline in Sleep Efficiency at End of Intervention
Time frame: Baseline and at 4 weeks
Sleep efficiency will be objectively assessed using wrist actigraphy (MotionWatch 8, Cambridge Neurotechnology Ltd., UK), worn on the non-dominant wrist during the night. Data will be sampled at 50 Hz and processed in 30-second epochs using MotionWare software (version 1.2.5). Sleep efficiency will be calculated as the percentage of time spent asleep relative to time in bed. Actigraphy-derived sleep efficiency will be averaged over 4 consecutive nights at four assessment time points: Baseline (pre-program), Early (after Session 1), Mid (after Session 5), and End (after Session 10). The primary outcome will be the change in mean sleep efficiency from baseline to the end of the intervention. Unit of Measure: Percentage (%) Scale: 0% to 100%; higher values will indicate greater sleep efficiency.
Change from Baseline in Sleep Fragmentation at End of Intervention
Time frame: Baseline and at 4 weeks
Sleep fragmentation will be objectively assessed using wrist actigraphy (MotionWatch 8, Cambridge Neurotechnology Ltd., UK), worn on the non-dominant wrist during the night. Data will be sampled at 50 Hz and processed in 30-second epochs using MotionWare software (version 1.2.5). Sleep fragmentation will be quantified using the actigraphy-derived fragmentation index, an activity-based measure reflecting the degree of sleep restlessness and fragmentation based on movement frequency and immobility phases during the sleep period. The fragmentation index will be averaged over 4 consecutive nights at four assessment time points: Baseline (pre-program), Early (after Session 1), Mid (after Session 5), and End (after Session 10). The primary outcome will be the change in mean sleep fragmentation from baseline to the end of the intervention. Unit of Measure: arbitrary units (a.u.); higher values will indicate greater sleep fragmentation.
Change from Baseline in Salivary Cortisol Concentration at End of Intervention
Time frame: Baseline and a 4 weeks
Objective stress will be assessed using salivary cortisol following standardized procedures. To minimize the influence of external factors on cortisol concentrations, participants will be instructed to follow standardized pre-assessment procedures. Circadian variation will be controlled by requiring participants to wake up at least three hours before testing, with all assessments scheduled after 11:30 a.m. Session 1 and Session 10 assessments will be scheduled at the same time of day for each participant to ensure comparable cortisol measurements across the intervention period. Cortisol concentrations will be determined using a validated salivary cortisol enzyme-linked immunosorbent assay (ELISA) protocol. The change in salivary cortisol concentration from baseline to the end of the intervention will be assessed. Unit of Measure: nmol/L higher cortisol concentrations will indicate higher physiological stress levels.

4 secondary outcomes

Change from Baseline in Insomnia Severity Index Score at End of Intervention
Time frame: Baseline and a 4 weeks
Change from Baseline in Sleep Quality at End of Intervention
Time frame: Baseline and at 4 weeks
Change from Baseline in Sleep Reactivity at End of Intervention
Time frame: Baseline and at 4 weeks
Change from Baseline in Perceived Stress at End of Intervention
Time frame: Baseline and at 4 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
Individual participant dataSharing planned: Undecided. A decision regarding the sharing of individual participant data has not yet been made. Any future data sharing will be considered in accordance with applicable ethical, legal, and data protection requirements

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Damien Léger, MD, PhD study director

Centre du Sommeil et de la Vigilance, Hôtel Dieu, Paris, France.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mechanized Massage (LPG Cellu M6 Alliance) in people with Stress (Psychology), run by Bescored at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Sleep Efficiency at End of Intervention (time frame: Baseline and at 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07811284.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.