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

Sleep Quality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05118191
• Other study ID #: 2106353559
• Status: Completed
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: October 30, 2023

Study information

• Verified date: March 2024
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 30, 2023
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Quality

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Rockefeller Neuroscience Institute at West Virginia University	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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.	Changes from baseline versus end of study week 8
Primary	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).	Changes from baseline versus end of study week 8
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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