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

NCT ID: NCT05118191

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-18
• Study Completion Date: 2023-10-30

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.

Conditions

Sleep Quality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

OOLER

Participants will use the OOLER device.

Group Type: ACTIVE_COMPARATOR

OOLER

Intervention Type: OTHER

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

Participants will use the Embr Wave 2 device.

Group Type: ACTIVE_COMPARATOR

EmbrWave

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

Victor Finomore

Director of Applied Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rockefeller Neuroscience Institute at West Virginia University

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

2106353559

Identifier Type: -

Identifier Source: org_study_id