Novel non-pharmacological insomnia treatment – a pilot study

Figures & data

Figure 1 Bioboosti device.

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 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.

Table 1 Insomnia symptoms and sleep outcomes before and after treatment with BioBoosti

	Pretreatment	Post-treatment	p
Subjective measures
PSQI score	12.6±133	8.5±3.7	0.001
ISI score	18.2±5.2	12.8±7.0	0.0008
KSS score	5.1±1.7	4.6±2.5	0.36
Visual Analog Scale score	5.7±2.8	4.0±3.3	0.03
ESS score	6.9±5.4	5.9±4.1	0.18
Sleep log mean TST, hours	6.8±1.5	7.3±1.8	0.03
Actigraphy-based sleep
TST, hours	6.9±1.6	6.8±0.9	0.71
Sleep onset latency, mins	11.2±10.2	14.2±10.7	0.22
Sleep efficiency, %	84.8±7.9	85.9±4.3	0.97
WASO, mins	54.2±26.9	42.2±13.6	0.07
Number of awakenings	34.2±11.1	32.8±9.0	0.60
EEG sleep architecture
TST, hours	7.6±1.6	7.6±1.3	0.85
WASO, mins	64.2±63.4	74.1±37.5	0.16
Stage N1, %	7.9±3.7	7.8±3.9	0.76
Stage N2, %	50.3±9.5	50.6±7.1	0.91
Stage N3, %	6.0±6.9	6.6±7.0	0.06
Stage REM, %	28.8±32.7	19.3±8.1	0.36

Notes: Sleepiness Scale; After sleep onset. The bold values represent statistically significant p-values.

Abbreviations: PSQI, Pittsburgh Sleep Quality Inventory; ISI, Insomnia Severity Index; KSS, Karolinska; ESS, Epworth Sleepiness Scale; TST, Total sleep time; WASO, Wake; REM, Rapid-eye-movement sleep.