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

NCT07811284 | Completed

• 1 other identifier: 2022-A01741-42
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress (Psychology)

Keywords

Massage intervention; Endermology; Stress; Sleep

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline and a 4 weeks

Secondary Outcomes (4)

• Change from Baseline in Insomnia Severity Index Score at End of Intervention

  Baseline and a 4 weeks

• Change from Baseline in Sleep Quality at End of Intervention

  Baseline and at 4 weeks

• Change from Baseline in Sleep Reactivity at End of Intervention

  Baseline and at 4 weeks

• Change from Baseline in Perceived Stress at End of Intervention

  Baseline and at 4 weeks

Study Arms (2)

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.

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.

Device: Sham Mechanized Massage (LPG Cellu M6 Alliance)

Interventions

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.

Experimental group (G-EXP)

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.

Sham-control group (G-CONT)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bescored: lead
• centre du sommeil et de la vigilance, APHP: collaborator
• European Sleep Center: collaborator

Study Sites (1)

beScored Institute

Valbonne, France, 06560, France

Location

Study Officials

• Damien Léger, MD, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 10, 2026
• Study Start: January 12, 2023
• Primary Completion: June 14, 2023
• Study Completion: June 14, 2023
• Last Updated: September 10, 2026

Record last verified: 2026-09

Locations

FR (1)