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. 2019 Sep 11:11:189-195.
doi: 10.2147/NSS.S198944. eCollection 2019.

Novel non-pharmacological insomnia treatment - a pilot study

Milena K Pavlova  1 , Véronique Latreille  1 , Nirajan Puri  1 , Jami Johnsen  1 , Salma Batool-Anwar  2 , Sogol Javaheri  2 , Paul G Mathew  1
Affiliations

Novel non-pharmacological insomnia treatment - a pilot study

Milena K Pavlova et al. Nat Sci Sleep. .

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: actigraphy; electroencephalography; insomnia; non-pharmacological treatment; sleep quality.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Bioboosti device.
Figure 2
Figure 2
Study schema. The structure of the study was as follows: (A) Baseline measurements: 1) 72-hr continuous EEG. 2) Actigraphy. 3) Diaries. (B) treatment period – 2 weeks, with continuous actigraphy and daily sleep log. (C) post-treatment: 72-hr EEG; sleep log and questionnaires.
Figure 3
Figure 3
Recruitment flow. The structure of recruitment was as follows: (A) Potential subject shows interest in the research study. (B) Subject is screened and then invited to enroll if criteria is met. (C) Enrollment. (D) Completion/termination of study.
See this image and copyright information in PMC

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