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

NCT05118191 | Completed

• 1 other identifier: 2106353559
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Quality

Keywords

Sleep; Commercial devices

Outcome Measures

Primary Outcomes (5)

• 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 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

• 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

• 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 Outcomes (7)

• Change in Subjective Epworth Sleepiness Scale measured via Questionnaire

  Weekly throughout study completion at 8 weeks

• Changes in Emotional Regulation as measured via ERQ

  Monthly from baseline through study completion at 8 weeks

• Changes in Perceived Stress as measured via PSS

  Weekly from baseline through study completion at 8 weeks

• Changes in Subjective Sleep as measured via PSQI

  Monthly from baseline through study completion at 8 weeks

• Changes in Subjective Anxiety as measured via the STAI

  Monthly from baseline through study completion at 8 weeks

Study Arms (2)

OOLER

ACTIVE COMPARATOR

Participants will use the OOLER device.

Other: OOLER

EmbrWave

ACTIVE COMPARATOR

Participants will use the Embr Wave 2 device.

Other: EmbrWave

Interventions

OOLER 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.

OOLER

EmbrWave 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.

EmbrWave

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female 18-50 years of age

You may not qualify if:

• Has a head diameter outside the range of 20.8-24 inches, or an approved head mounted EEG device doesn't otherwise fit properly
• 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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

Rockefeller Neuroscience Institute at West Virginia University

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Applied Research

Model Details: 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.

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 11, 2021
• Study Start: October 18, 2021
• Primary Completion: November 10, 2022
• Study Completion: October 30, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

US (1)