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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sleep Quality

Intervention / Treatment
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* Other: OOLER
* Other: EmbrWave


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Male or female 18-50 years of age Exclusion Criteria: Has a head diameter outside the range of 20.8-24 inches, or an approved head mounted EEG device doesn't otherwise fit properly Participants home is not air conditioned (exclusion for the OOLER only) Is pregnant or actively trying to become pregnant Has a known or diagnosed sleep disorder Females who have become menopausal or are exhibiting signs or symptoms of becoming perimenopausal Females who are unable to identify when their monthly menstrual period will occur Individuals who work during the night shift or have significantly abnormal sleep schedule Has undergone travel across more than two collective time zones in the last two weeks Individuals who intend to have any significant medical procedures scheduled to occur within 12 weeks of enrollment Individuals who have intentions, or have discussed with their doctor, about adding or making any alterations to their prescribed medications within 12 weeks of enrollment Individuals who have any travel plans or other obligations within 12 weeks of enrollment that would prevent them from completing study requirements and attending required laboratory visits Individuals who intend to make significant alterations to their sleeping patterns within 12 weeks of enrollment. This may include, but is not limited to, changes such as moving, getting a new mattress, having someone move in with them, etc. Does not meet the ACSM's guidelines for exercise prescription. This is defined as: Presenting with an absolute contraindication OR Has a known cardiovascular, pulmonary, renal, metabolic disease, or other chronic illness Presents with symptoms indicating cardiovascular, pulmonary, renal, or metabolic disease Presenting with two or more relative contraindications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will undergo 4 weeks of baseline data collection followed by 4 weeks of data collection while utilizing an assigned sleep augmentation device each night during sleep. Augmentation devices will be assigned with respect to 1) eligibility of inclusion/exclusion criteria of each device and 2) interest in participating with the available devices based upon responses in the qualifying survey on sleep preferences. If participants indicated that they were willing to try both the OOLER & the Embr Wave, & were eligible to do so, they will be randomly assigned a device based upon current availability. Women who experience menstrual flow will be scheduled to ensure that flow occurs on weeks 4 & 8 for consistency. Participants will complete daily, weekly, & monthly surveys, as well as weekly & monthly cognitive assessments. Participants will also have their sleep monitored nightly via the OURA ring & EEG headband. An additional exit survey will be completed at the end of week 8.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OOLER<br>Participants will use the OOLER device. | Other: OOLER<br>* 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.<br>|
| Active Comparator: EmbrWave<br>Participants will use the Embr Wave 2 device. | Other: EmbrWave<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Daily from baseline through study completion at 8 weeks | 
| Change in Sleep Quantity as measured by EEG | Sleep stage duration (and the cumulative sleep duration) will be quantified each night via the Dreem headband, which uses EEG for automatic sleep stage scoring. | 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. | 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. | Daily from baseline through study completion at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Subjective Athens Insomnia Scale measured via Questionnaire | Participants will complete previously validated questionnaires as often as weekly. Athens Insomnia Scale (AIS) - eight-item questionnaire assessing sleep behaviors on a scale of 0 to 3. Higher scores = greater difficulty. | Weekly throughout study completion at 8 weeks | 
| 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 | Weekly throughout study completion at 8 weeks | 
| Change in Subjective Insomnia Severity Index measured via Questionnaire | Participants will complete previously validated questionnaires as often as weekly. Insomnia Severity Index (ISI) - seven-item questionnaire assessing sleep behaviors on a scale of 0 to 3. Higher scores = increased severity. | Weekly throughout study completion at 8 weeks | 
| Change in Subjective Restorative Sleep Questionnaire | Participants will complete previously validated questionnaires as often as weekly. Restorative Sleep Questionnaire (RSQ) - nine-item questionnaire assessing sleep behaviors on a scale of 0 to 5. Higher scores = better sleep | Weekly throughout study completion at 8 weeks | 
| Change in Subjective Patient Reported Outcomes Measurement Information System measured via Questionnaire | Participants will complete previously validated questionnaires as often as weekly. Patient Reported Outcomes Measurement Information System (PROMIS) - seven item questionnaire assessing sleep behaviors on a scale of 0 to 5. Higher scores = healthier subject | Weekly throughout study completion at 8 weeks | 
| Subjective Sleep Preferences measured via Questionnaire | At intake, a custom baseline questionnaire will be completed to record each participants sleep preferences and common behaviors. These sleep preferences will be used to identify if intervention tends to be more or less successful for certain individuals based upon predetermined qualities. | Once at the beginning of week 1 | 
| Changes in Conflict Management via Questionnaire | Participants ability to manage conflict and the strategies in which they approach conflict will be assessed via the Conflict Management Questionnaire. This questionnaire scores the management of various situations based upon the participant responses (definitely true, true, tends to be true, tends not to be true, not true, definitely not true) and classifies the highest scoring response category as being the participant's preferred method of handing conflict. Scores of the response categories will be compared. | Monthly from baseline through 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). | 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. | 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. | 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. | 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. | 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. | Once at the end of week 8 | 
| Change in Cognitive Performance via Stroop Task | Participants will complete the Stroop Task at intake and once weekly throughout the study on a computer. The task requires participants to respond to the presentation of a word by clicking the key associated with the ink color rather than the meaning of the word. Participants will be monitored for speed and accuracy of responses. | Weekly from baseline through study completion at 8 weeks. | 
| Change in Response Inhibition via SART 2 | Participants will complete the SART 2 task at intake and once weekly throughout the study on a computer. The task requires participants to respond, or refrain from responding, to the presentation of a number; a predetermined number is provided at the start of the task that participants are asked to refrain from responding to. Participants will be monitored for speed and accuracy of responses. | Weekly from baseline through study completion at 8 weeks. | 
| Change in Attentional Vigilance via Mackworth Clock Task | Participants will complete the Mackworth Clock task at intake and once weekly throughout the study on a computer. The task requires participants to watch the second hand of a clock across five minutes and respond as quickly as possible to skips in the clock's second hand by pressing a key. Participants will be monitored throughout the task for speed and accuracy of responses. | Weekly from baseline through study completion at 8 weeks. | 
| Change in Mental Rotation via Computer Task | Participants will complete the Mental Rotation task at intake and once monthly throughout the study on a computer. The task requires participants to respond as quickly as possible by select from two pictures that accurately depicts the same object that is presented in a different position in a third picture. 10 warm up trials will be completed followed by 10 test trials. Participants will be monitored throughout the task for speed and accuracy of responses. | Monthly from baseline through study completion at 8 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep, Commercial devices