Scientific proof of Somnicalme's effectiveness

Clinically proven to help you sleep better

Somnicalme® isn’t just another sleep aid. It’s a device backed by real science.

In a double-blind, randomized, placebo-controlled study involving over 200 adults with chronic insomnia, Somnicalme demonstrated significant improvements in key areas of sleep health.

📊 Results that speak volumes

✅ 38% faster to fall asleep
Users in the active group experienced significantly reduced sleep latency compared to the placebo (p < 0.05).

✅ 29% fewer nighttime awakenings
WASO was significantly lower in the Somnicalme group versus placebo (p < 0.05).

✅ 51% improvement in perceived sleep quality
Participants reported more restorative sleep and reduced fatigue upon waking (p < 0.01).

✅ 74% said they would continue using Somnicalme
Strong adherence and satisfaction after 4 weeks of use.

"This study supports the potential of gentle, non-invasive microcurrent stimulation as an effective complementary tool for managing chronic insomnia."
— Dr. Theo Lemaire, Lead Researcher, Paris Sleep Institute

🌐 The study: detailed overview

The clinical trial assessing the efficacy of Somnicalme® was conducted under strict methodological conditions to ensure the validity and reproducibility of the results.

Design:
A double-blind, randomized, placebo-controlled parallel-group trial, fully compliant with CONSORT guidelines for the reporting of randomized clinical trials.

Sample Size:
A total of 217 participants (112 in the Somnicalme group, 105 in the placebo group) were enrolled. Sample size was determined via power analysis to detect a medium effect size (Cohen’s d = 0.5) with 80% power at a 95% confidence level.

Participant Profile:
Adults aged 24 to 67 years, all diagnosed with chronic primary insomnia (ICSD-3 criteria) and a baseline Insomnia Severity Index (ISI) ≥ 15.

  • Inclusion Criteria:

    • Sleep latency > 30 minutes, at least 3 nights/week

    • Total sleep time < 6.5 hours/night

    • Sleep issues persisting for over 3 months

  • Exclusion Criteria:

    • Use of hypnotic or psychotropic medication in the last 4 weeks

    • Obstructive sleep apnea (AHI > 5/h, confirmed by polysomnography)

    • Major depressive episode (DSM-5 criteria)

    • Irregular circadian rhythm (e.g., night-shift work)

Study Duration:
28 nights of use for 20 minutes before bedtime, following a 7-day baseline assessment period.

Blinding Measures:
Placebo devices were identical in appearance and handling but delivered no current. Allocation was handled externally by an independent biostatistician.

Measurement Tools:

  • Subjective: ISI, PSQI, ESS, and Daily Sleep Diary

  • Objective: Continuous actigraphy (GENEActiv 60 Hz) over 35 days

Primary Outcomes:

  • Sleep Onset Latency (SOL)

  • Wake After Sleep Onset (WASO)

  • Sleep Efficiency (SE)

  • Sleep Satisfaction Score (SSS)

Secondary Outcomes:

  • Daytime alertness (Karolinska Sleepiness Scale)

  • Mood (Beck Depression Inventory-II)

Statistical Methods:
A linear mixed model (LMM) was used to test group × time effects, adjusting for baseline differences. Missing data were addressed via multiple imputation (MCMC).

Join the thousands sleeping better
Return to the main page