An interventional study of OOLER and EmbrWave in Sleep Quality, sponsored by West Virginia University. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-08.
Sponsored by West Virginia University · Not applicable, Interventional, and Basic science
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.
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.
West Virginia University is the lead sponsor of 155 studies on the registry; 35 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Does not meet the ACSM's guidelines for exercise prescription. This is defined as:
Presenting with an absolute contraindication OR
Participants will use the OOLER device.
Other: OOLER
Participants will use the Embr Wave 2 device.
Other: EmbrWave
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.
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.
Change in Nocturnal Heart Rate as measured by OURA Ring
Heart rate (beats per minute) will be quantified throughout the night via the OURA ring.
Time frame: Daily from baseline through study completion at 8 weeks
Change in Subjective Sleep Quality measured via Questionnaire
A custom daily morning questionnaire will be used to record how a participant feels the quality of their sleep was the previous night (e.g. 1, very poor; 10 excellent). This questionnaire will be taken on the participants smartphone within 30 minutes of waking.
Time frame: Daily from baseline through study completion at 8 weeks
Change in Nocturnal Heart Rate Variability as measured by OURA Ring
Heart rate variability will be quantified throughout the night via the OURA ring.
Time frame: Daily from baseline through study completion at 8 weeks
Change in Eriksen Flanker Task
The Flanker Task is a response inhibition test used to assess the participant's ability to suppress a response that is inappropriate based on the task rules. Participants are to respond, left or right, to the direction of the middle arrow (target arrow) of five aligned items. The task consists of congruent stimulus (the direction of the target arrow and flanker arrows are the same), incongruent stimulus (the direction of the target arrow is opposite of the flanker arrows), and neutral stimulus (flanker items are different then the target arrow). The dependent variable is the measurement of reaction time to select the direction of the target arrow.
Time frame: Changes from baseline versus end of study week 8
Change in Psychomotor Vigilance Task
A reaction time test that measures a person's sustained attention to a cue presented on a screen at random inter-stimulus intervals. In addition to the measures of reaction time to correct responses the errors of commission (responding when there is not response cue) and omission (failing to respond to a response cue).
Time frame: Changes from baseline versus end of study week 8
Change in Subjective Epworth Sleepiness Scale measured via Questionnaire
Participants will complete previously validated questionnaires as often as weekly. Epworth Sleepiness Scale (ESS) - eight-item questionnaire assessing sleep behaviors on a scale of 0 to 3. Higher scores = increased average sleep propensity in daily life
Time frame: Weekly throughout study completion at 8 weeks
Changes in Emotional Regulation as measured via ERQ
Participants' ability to regulate their emotions appropriately will be quantified via the previously validated Emotional Regulation Questionnaire (ERQ), in which participants will indicate how much they agree with each statement (1, strongly disagree; 7, strongly agree).
Time frame: Monthly from baseline through study completion at 8 weeks
Changes in Perceived Stress as measured via PSS
Participants' perceived stress will be quantified via the previously validated Perceived Stress Scale (PSS), which asks participants to report on the frequency of various experiences (0, never; 4, very often) and final scoring suggests lower scores to be associated with lower levels of stress.
Time frame: Weekly from baseline through study completion at 8 weeks
Changes in Subjective Sleep as measured via PSQI
Participant's subjective reports of sleep quality will be quantified through the previously validated Pittsburgh Sleep Quality Index (PSQI). Questions are scored into multiple components to determine sleep difficulty in various areas, where higher scores are indicative of greater sleep difficulties; these scores will be compared across timepoints.
Time frame: Monthly from baseline through study completion at 8 weeks
Changes in Subjective Anxiety as measured via the STAI
Participants will complete the previously validated State Trait Anxiety Index (STAI) as a measure of subjective anxiety, where higher scores are suggestive of greater anxiety.
Time frame: Monthly from baseline through study completion at 8 weeks
Changes in Sleep Disturbances as measured via the Sleep Disorders Questionnaire
Participants will complete a 34 item checklist that has been previously used for screening of a potential sleep disorder; the more items that the participant feels applies to them, the higher the likelihood of the individual having a sleep disorder.
Time frame: Monthly from baseline through study completion at 8 weeks
Subjective Success of Commercial Device measured via Questionnaire
Following completion of the study, a custom questionnaire will record how successful the participant believes their assigned device was for improving their sleep and well-being.
Time frame: Once at the end of week 8
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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West Virginia University