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COMPLETED
NCT07811284
NA

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

Sponsor: Bescored

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

20 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2023-01-12

Completion Date

2023-06-14

Last Updated

2026-09-10

Healthy Volunteers

Yes

Interventions

DEVICE

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

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.

Locations (1)

beScored Institute

Valbonne, France, France