作者
Milena Pavlova,P Matthew,L Veronique,Nirajan Puri
摘要
Objective: Assess the effectiveness of BioBoosti, a non-pharmacological device, for the treatment of insomnia. Background: Insomnia is a highly prevalent disorder frequently associated with loss of productivity, poor health outcomes, and higher healthcare utilization. Commonly used drugs to treat insomnia can be ineffective, side effect prone, and expensive. BioBoosti is a device that emits a micromagnetic field which is thought to have therapeutic benefit. In this prospective pilot study, 16 adults (age range: 18 -74) diagnosed with insomnia used BioBoosti for 2 weeks daily. Subjects held the device in each hand for 8 minutes, for 6 cycles. Subjective sleep measures: Pittsburgh Sleep Quality Inventory (PSQI), Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), and Karolinska sleepiness scale (KSS) were collected before and after 2 weeks of treatment. Subjects wore actigraphy throughout the study, allowing objective validated comparisons of total sleep time, sleep latency and efficiency, wake after sleep onset, and number of awakenings. After 2 weeks of BioBoosti use, subjects reported improved sleep quality (PSQI: before, 13.5 ± 3.1 versus after, 8.4 ± 3.9, p=0.001) and reduced insomnia symptoms (ISI: before, 19.2 ± 4.7 versus after, 13.1 ± 7.4, p=0.003). Sleepiness, measured by KSS was reduced after treatment (0.3 ± 0.3 after, versus 0.5 ± 0.2 before). No statistically significant changes were found in the ESS. Actigraphy analysis revealed a significantly reduced WASO (51.9 ± 17.2 before versus 41.9 ± 29.1 after treatment, p=0.03). No significant side effects were noted by any of the participants. Based on these data, BioBoosti appears to be an effective and well tolerated device for the treatment of insomnia. Future placebo controlled studies with a larger sample size are needed to confirm our preliminary findings. Biomobie, inc.