Stress (Psychology)
Conditions
Keywords
Massage intervention, Endermology, Stress, Sleep
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.
Interventions
DEVICEMechanized 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.
DEVICESham 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.
Sponsors
Bescored
centre du sommeil et de la vigilance, APHP
European Sleep Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Sleep Efficiency at End of Intervention | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Insomnia Severity Index Score at End of Intervention | Baseline and a 4 weeks | 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. |
| Change from Baseline in Sleep Quality at End of Intervention | Baseline and at 4 weeks | 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 |
| Change from Baseline in Sleep Reactivity at End of Intervention | Baseline and at 4 weeks | 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. |
| Change from Baseline in Perceived Stress at End of Intervention | Baseline and at 4 weeks | 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. |
Countries
France
Contacts
STUDY_DIRECTORDamien Léger, MD, PhD
Centre du Sommeil et de la Vigilance, Hôtel Dieu, Paris, France.
Outcome results
None listed