Personalized Sleep Microclimate Intervention for Chronic Insomnia: An IoT-Driven Environmental Design and Validation Study

INTRODUCTION: Chronic Insomnia Disorder (CID) is a common public health concern associated with physiological hyperarousal and impaired thermoregulation during sleep onset. Existing pharmacological and psychological treatments often overlook the importance of the sleep environment in facilitating physiological readiness for sleep. OBJECTIVES: This study aims to evaluate the efficacy of a Personalized Microclimate Control (PMC) system—an IoT-driven, adaptive bedroom environmental intervention—in improving insomnia symptoms and objective sleep outcomes in individuals with CID. METHODS: A randomized, controlled, parallel-group trial was conducted with 120 participants diagnosed with CID. Participants were assigned to either the PMC intervention group or a Standard Bedroom Environment (SBE) control group for 8 weeks. Real-time physiological data (skin temperature, HRV) were used to automatically adjust environmental parameters (temperature, light). Primary outcomes included Insomnia Severity Index (ISI) scores and objective Total Sleep Time (TST); secondary outcomes included Skin Temperature Drop Rate (STDR) and its correlation with symptom improvement. RESULTS: The PMC group demonstrated significantly greater improvements across all outcomes compared with the SBE group. ISI scores decreased by 7.47 points in the PMC group versus 2.28 points in the SBE group. TST increased by 43.65 minutes compared to 12.73 minutes in the control group. The PMC system also produced a significantly higher STDR, which was strongly correlated with ISI reduction (r = –0.712, p < 0.001). CONCLUSION: The findings provide strong evidence that IoT-based personalized environmental design is an effective and scalable non-pharmacological intervention for CID. By integrating smart technology, sleep medicine, and environmental science, the PMC system provides a user-centric and mechanistically supported approach to improving sleep in individuals with insomnia.