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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
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 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.
beScored Institute
Valbonne, France, France
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and a 4 weeks
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline and at 4 weeks
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