Clinical trial NCT05118191: Efficacy of Commercially Available Technology in Augmenting Sleep and Well-being
Official title: Efficacy of Commercially Available Technology in Augmenting Sleep and Well-being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Quality
Keywords: Sleep
Commercial devices
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: 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:

  1. Presenting with an absolute contraindication OR

     1. Has a known cardiovascular, pulmonary, renal, metabolic disease, or other chronic illness
     2. Presents with symptoms indicating cardiovascular, pulmonary, renal, or metabolic disease
  2. Presenting with two or more relative contraindications

Primary outcomes:
measure: Change in Nocturnal Heart Rate as measured by OURA Ring
timeFrame: Daily from baseline through study completion at 8 weeks
measure: Change in Subjective Sleep Quality measured via Questionnaire
timeFrame: Daily from baseline through study completion at 8 weeks
measure: Change in Nocturnal Heart Rate Variability as measured by OURA Ring
timeFrame: Daily from baseline through study completion at 8 weeks
measure: Change in Eriksen Flanker Task
timeFrame: Changes from baseline versus end of study week 8
measure: Change in Psychomotor Vigilance Task
timeFrame: Changes from baseline versus end of study week 8
Secondary outcomes:
measure: Change in Subjective Epworth Sleepiness Scale measured via Questionnaire
timeFrame: Weekly throughout study completion at 8 weeks
measure: Changes in Emotional Regulation as measured via ERQ
timeFrame: Monthly from baseline through study completion at 8 weeks
measure: Changes in Perceived Stress as measured via PSS
timeFrame: Weekly from baseline through study completion at 8 weeks
measure: Changes in Subjective Sleep as measured via PSQI
timeFrame: Monthly from baseline through study completion at 8 weeks
measure: Changes in Subjective Anxiety as measured via the STAI
timeFrame: Monthly from baseline through study completion at 8 weeks
measure: Changes in Sleep Disturbances as measured via the Sleep Disorders Questionnaire
timeFrame: Monthly from baseline through study completion at 8 weeks
measure: Subjective Success of Commercial Device measured via Questionnaire
timeFrame: Once at the end of week 8
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Rockefeller Neuroscience Institute at West Virginia University
state: West Virginia
Study officials:
References: