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Completed
NCT07811284
Effects of Mechanical Massage on Sleep Quality, Immunity, and Stress
Conditions: Stress (Psychology)
Sex: All
Ages: 20 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 32
Sponsor: Bescored
Location: beScored Institute Valbonne France
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07811284). StuddyBuddy aggregates publicly available trial information.