A total of twelve patients including 7 men and 5 women completed one month of PSS therapy. Mean age was 55.1 years (range 29 to 80 years).  At baseline, 1 patient (8%) had minimal symptoms (total scores: 0-7), 4 (33%) had sub-threshold insomnia (total scores: 8-14), 3 (25%) had moderately severe insomnia (total scores: 15-21), and 3 (25%) had severe insomnia (total scores 22-28).   Compliance with the treatment protocol was excellent based on patient reporting and our ability to query the devices for a log of treatment times. No adverse events were reported related to device use.

By week 4, 8 patients (75%) had overall minimal to no insomnia symptoms, 2 (17%) had sub-threshold insomnia, and the remaining 2 patients (17%) had moderate insomnia (Table 2). Except for 1 question response, all responses of dissatisfaction by week 4 came from 2 patients with severe insomnia at baseline (total scores 22 and 25 at baseline). For every question answered, all patients had either improved symptoms or at least unchanged scores by week 4. The average total change from baseline score was -10.3 points (baseline: 16.5 vs. week 4: 6.2; Table 2).

Overall, patients had statistically significant improvements for every individual survey question by week 4. The composite score was improved from baseline, with an overall median score of 2 (IQR: 1.25 – 2.75, min-max: 1-4) at baseline compared to 0.5 (IQR: 0 – 0.25, min-max: 0-2) by week 4 (MD = -1 (95% CI: -2; -1), p < 0.001; Table 3), signaling typically moderate insomnia at baseline vs. typically minimal to no symptoms by week 4. Overall, the predicted probability of obtaining the best outcome (score=0) was 9% at baseline vs. 53% by week 4. Conversely, the predicted probability of obtaining the worst outcome (score=3) was 12% at baseline vs. 1% at week 4 (Table 4). The overall cumulative odds ratio was 11.9 (p < 0.001), suggesting that on average, the odds of moving from one score to a lower (improved) score at week 4 compared to the baseline are 11.9 times higher than moving to a neutral or worse score. Overall likelihood of improved insomnia symptoms and patient-specific trends are displayed in Figure 1.

The impact of normal sleep on health and wellness has been well-described. (1-5) In addition to impairing alertness and affecting ability to work, sleep disturbances have been linked to cardiovascular disorders, stroke, and cognitive decline.(1-8,20-24) Sleep is of critical importance for normal neuronal development and functioning, and lack of proper sleep has been linked to impairment of attention, memory, mood, and behavior (25-6) Although multiple pharmacological treatments have been utilized to improve sleep, many of these fail to restore normal sleep patterns, and an increasing emphasis has been placed on improved sleep hygiene and various relaxation techniques to improve sleep quality. 2781112

Our previous work demonstrated a statistically significant improvement in symptoms of PTSD, anxiety, and depression with the use of PSS. 1718 The scientific bases for such improvements may be related to the role played by sensory processing in anxiety, depression, and PTSD. Haricharichan et al postulated that alterations in the neural pathways important for processing sensory input have a cascading effect on the ability to perform higher cognitive functions implying that abnormal sensory processing may be contributory and associated with these disorders 27. Similarly, impaired sensory processing has been implicated in sleep disturbances, and various forms of sensory stimulation have been utilized to improve sleep. These include the use of relaxing music, aromatherapy, minimizing bright lights or the use of specific lighting to restore normal circadian rhythms, the avoidance of particular foods or stimulants, and tactile input such as from massage or weighted blankets 2829303132333435363738. It is noteworthy that individuals with autism, elderly nursing home residents, and dementia patients all appear to be disproportionately affected by sleep disorders and seem to respond to sensory stimulation 3940414243. Based on these findings, we hypothesized that tactile PSS might be beneficial in improving sleep.

Our survey results suggest promising preliminary evidence of improved insomnia symptoms after 4 weeks of PSS therapy. All patients had overall improvements by week 4, with statistically significant improvements for every individual survey question answered. Results from our study suggest that, on average, patients had typically moderate insomnia symptoms at baseline compared to typically minimal or no symptoms by week 4. It should be noted that two patients who initially had severe insomnia still had moderate insomnia symptoms by the end of the study. Although patients were not uniformly free of insomnia symptoms by the end of the study, this data suggests that patients of varying degrees of insomnia severity may benefit from PSS therapy.