NCT05118191

Efficacy of Commercially Available Technology in Augmenting Sleep and Well-being

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: West Virginia University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The objective of this research study is to assess how the implementation of various commercially available devices affect sleep quality, sleep structure, nocturnal physiology, subjective wellness, recovery from stressors, and resultant effects on performance and well-being.

Detailed description

Sleep is a vital process for memory, cognitive performance, physical recovery, hormonal balance, and the repair of cellular damage, among numerous other functions. Despite its importance for maintaining one's health, it is amongst the most variable human behaviors experienced across the population. While many individuals fail to allocate sufficient time in their schedules for sufficient sleep, many individuals allocate plenty of time but struggle to receive efficient, and good quality sleep. In both cases, failure of the body to receive its required combination of enough and efficient enough sleep can result in significant consequences, including increased rates of disease development. In an effort to help with these issues, which affect a significant portion of the adult population, commercial companies have sought to combine science, convenience, and good hygienic practices in the development of products aimed toward augmenting sleep. A wide range of products have hit the market including supplements (i.e. melatonin, melatonin infused products, GABA), sound producing devices (i.e. white noise machines), wearable products (i.e. sleep masks, special pajamas), and physiological modification devices and routines (i.e. temperature modulators, meditation), among dozens of other products, all with varying degrees of validity and scientific backing. Thermoregulatory products, the types of technologies utilized herein, have a great deal of scientific backing in how they have the potential to enhance sleep behaviors. Given the critical reduction in core body temperature that is needed at sleep onset, careful modulation of reduced body temperature is vital for falling asleep, staying asleep, and receiving good quality sleep. While these products demonstrate promising potential, further research is needed to identify the efficacy of these products in enhancing sleep. Further, it is of high interest what aspects of sleep can be enhanced via thermoregulation, what factors contribute to the degree of intervention impact, and what subsequent facets of overall well-being and performance are most improved by this type of sleep modulation.

Conditions

• Sleep Quality

Interventions

Type	Name	Description
OTHER	OOLER	Following the baseline block (first four weeks), participants will use the OOLER device to power a cooling mattress pad each night during sleep for four weeks.
OTHER	EmbrWave	Following the baseline block (first four weeks), participants will use the Embr Wave 2 device to provide pulsed warm sensations to the inner wrist each night during sleep for four weeks.

Timeline

• Start date: 2021-10-18
• Primary completion: 2022-11-10
• Completion: 2023-10-30
• First posted: 2021-11-11
• Last updated: 2024-03-08

Locations

1 site across 1 country: United States