Novel non-pharmacological insomnia treatment – a pilot study

Abstract

Objective

The objective of this prospective pilot study was to examine the effects of a novel non-pharmacological device (BioBoosti) on insomnia symptoms in adults.

Methods

Subjects with chronic insomnia were instructed to hold the device in each hand for 8 mins for 6 cycles on a nightly basis for 2 weeks. Outcomes tested included standardized subjective sleep measures assessing sleep quality, insomnia symptoms, and daytime sleepiness. Sleep was objectively quantified using electroencephalogram (EEG) before and after 2 weeks of treatment with BioBoosti, and wrist actigraphy throughout the study.

Results

Twenty adults (mean age: 45.6±17.1 y/o; range 18–74 y/o) were enrolled in the study. No significant side effects were noted by any of the subjects. After 2 weeks of BioBoosti use, subjects reported improved sleep quality (Pittsburgh Sleep Quality Index: 12.6±3.3 versus 8.5±3.7, p=0.001) and reduced insomnia symptoms (Insomnia Severity Index: 18.2±5.2 versus 12.8±7.0, p<0.001). Sleepiness, as assessed by a visual analog scale, was significantly reduced after treatment (5.7±2.8 versus 4.0±3.3, p=0.03).

Conclusion

BioBoosti use yielded an improvement in insomnia symptoms. Larger placebo-controlled studies are needed to fully assess efficacy.

Keywords:

• insomnia
• non-pharmacological treatment
• sleep quality
• actigraphy
• electroencephalography

Acknowledgments

The authors wish to thank all the subjects for participation in this study. This work was supported by Biomobie Inc. Part of the findings have been presented in abstract form as posters at the 2018 meetings of the American Academy of Neurology and the American Academy of Sleep Medicine.

Informed consent

Participant provided written informed consent, and the study was conducted in accordance with the Declaration of Helsinki. We do not indent to publish the data elsewhere, but if requested, de-identified data can be shared, according to current HIPPAA law. We will have to also ask the IRB for approval. Sleep log measures, actigraphy, ISI/PSQI/ESS score, and any adverse event reports may be shared upon request for 3 years following the conclusion of the study. The clinical trial identifier is NCT02924116.

Author Contributions

MKP designed and led the study, performed most data interpretation and prepared the first manuscript draft. VL performed data analysis, contributed to interpretation and manuscript preparation (performed technical editing, table preparation, and draft revision). NP was the study coordinator, leading recruitment of subjects, study completion and data organization. PGM, assisted in data analysis, manuscript preparation, and editing. SJ, JJ, and SBA also assisted with data acquisition, manuscript preparation, and editing. All authors contributed to data analysis, drafting or revising the article, gave final approval of the version to be published and agree to be accountable for all aspects of the work.

Disclosure

Research funding for the study included a grant from Biomobie, Inc., to the Brigham and Women’s hospital which included coverage of study cost (testing, subjects remuneration, fees), and partial salary support covering the time involved in the study for Dr Pavlova (principal investigator), Mr Puri (research coordinator), and Dr Latreille (data analysis). Dr Matthew has received non-monetary compensation related to a similar project. Dr Matthew also reports non-financial support from BioMobie, during the conduct of the study. Drs Batool, Javaheri, and Johnsen have no relevant financial relationships. Drs Pavlova and Latreille have received also funding from the Trustee Fund, unrelated to this study. Dr Pavlova has received funding also from Lundbeck, Inc. and Jazz Pharmaceuticals for research unrelated to this study. Dr Latreille has received funding by the Canadian Institute of Health, unrelated to this study. Dr Javaheri is a consultant for Jazz Pharmaceuticals on treatment of type 2 narcolepsy. The authors report no other conflicts of interest in this work.