2016 Volume 15 Issue 1 Pages 4-16
Objective : This study was to examine the effects of a sleep pad, AlphaSlim®, on patients with sleep disorders. Its physiological effects, the impact on sleep and the quality of life, and product safety were investigated.
Methods : Participants were divided into Active group and Dummy group (as a control) by envelop method. Both Active group and Dummy group were requested to sleep on AlphaSlim® and ordinary sheets respectively for two months, and underwent objective as well as subjective assessments. The data collected from each group were compared.
Results : 20 subjects completed the experiment (9 belonged to Active group and 11 to Dummy group). Athens Insomnia Scale (AIS) : Sleep disorders in Active group significantly improved following the trial. Comprehensive Health Check for Workers (CHCW) : The results obtained from Active group showed a significant improvement after the trial while those from Dummy group remained unchanged. It follows that the quality of life of Active group improved. Sense of Coherence (SOC) Questionnaire : The results showed that there was a significant improvement in Active group after the trial while Dummy group reported no change. Blood test, Urinalysis, Chest X-P (used as a safety evaluation) : The clinical data obtained both prior to and subsequent to the experiment revealed that none of the participants had abnormalities. Head-up tilt test and heart rate variability (HRV) analysis : There was a significant improvement in high frequency components (HF amp) of the subjects in Active group following the experiment. Antioxidant defense system : Active group experienced a significant fall in the d-ROMs test after the experiment, which meant a positive change. The modified ratio of this group, which indicates the antioxidant potential, also improved significantly. Hemodynamics (head-up tilt test) : Systolic blood pressure (SBP) and the heart rate of Active group taken in a horizontal position dropped significantly following the experiment. There were increase tendency in stroke volume(SV), cardiac index(CI), but decrease tendency in total peripheral resistance (TPR) of this group. Cortisol, DHEA-S, Catecholamine, ADH, ACTH : A drop in the noradrenaline level was observed in Active group after the trial. There had been no significant difference of the DHEA-S level between Active and Dummy groups prior to the experiment, but the results obtained afterwards showed a significant increase in Active group.
Conclusions : AlphaSlim® had favorable effects on people with sleep disorders. Without causing any harm, it enabled the participants to have better sleep and better quality of life. It even helped them to become confident about their life. The results of objective assessments were also supporting. HRV analysis revealed the improvement of the parasympathetic nervous system. The d-ROMs and the BAP tests showed the decrease of oxidative stress and the increase of the antioxidant potential. There were positive effects on the noradrenaline level and the DHEA-S level the way they could boost homeostasis. Thus, using a proper sleep tool like AlphaSlim® not only helped to improve the quality of sleep. It also helped to normalize the homeostatic balance of the body that tended to be disrupted during the day when people were busy surviving a stressful life. It was evidenced that AlphaSlim® had the ability to improve homeostasis.