Sleep QualityNCT05118191
Efficacy of Commercially Available Technology in Augmenting Sleep and Well-being
A study testing OOLER and EmbrWave in people with Sleep Quality, run by West Virginia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality
- What is being tested?
- OOLER and EmbrWave
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2021to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female 18-50 years of age
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rockefeller Neuroscience Institute at West Virginia University
Morgantown, West Virginia, 26505
About this study
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.
Read the 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
- Being tested
- OOLER, EmbrWave
- Keywords
- Sleep, Commercial devices
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OOLEROther
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.
EmbrWaveOther
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.
| Study group | Role | What they receive |
|---|---|---|
| OOLER | Active comparator | Participants will use the OOLER device. Receives: Other: OOLER |
| EmbrWave | Active comparator | Participants will use the Embr Wave 2 device. Receives: Other: EmbrWave |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Changes from baseline versus end of study week 8
Secondary outcomes (7)
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
Measured: Weekly throughout 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Once at the end of week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start18 Oct 2021
- Primary completion10 Nov 2022
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Finomore, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118191
- Sponsor's protocol ID
- 2106353559
- Status last verified
- Mar 2024
- First submitted
- 29 Oct 2021
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Commercially Available Technology in Augmenting Sleep and Well-being
- ClinicalTrials.gov ID
- NCT05118191
- Acronym / sponsor ID
- 2106353559
- Conditions
- Sleep Quality
- Keywords
- Sleep, Commercial devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| OOLER | Active comparator | Other: OOLERParticipants will use the OOLER device. |
| EmbrWave | Active comparator | Other: EmbrWaveParticipants will use the Embr Wave 2 device. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male or female 18-50 years of age
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OOLERFollowing 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. | Other | OOLER |
| EmbrWaveFollowing 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. | Other | EmbrWave |
Primary outcome
Change in Nocturnal Heart Rate as measured by OURA Ring
Time frame: Daily from baseline through study completion at 8 weeks
Heart rate (beats per minute) will be quantified throughout the night via the OURA ring.
Change in Subjective Sleep Quality measured via Questionnaire
Time frame: Daily from baseline through study completion at 8 weeks
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.
Change in Nocturnal Heart Rate Variability as measured by OURA Ring
Time frame: Daily from baseline through study completion at 8 weeks
Heart rate variability will be quantified throughout the night via the OURA ring.
Change in Eriksen Flanker Task
Time frame: Changes from baseline versus end of study week 8
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.
Change in Psychomotor Vigilance Task
Time frame: Changes from baseline versus end of study week 8
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).
7 secondary outcomes
Change in Subjective Epworth Sleepiness Scale measured via Questionnaire
Time frame: Weekly throughout study completion at 8 weeks
Changes in Emotional Regulation as measured via ERQ
Time frame: Monthly from baseline through study completion at 8 weeks
Changes in Perceived Stress as measured via PSS
Time frame: Weekly from baseline through study completion at 8 weeks
Changes in Subjective Sleep as measured via PSQI
Time frame: Monthly from baseline through study completion at 8 weeks
Changes in Subjective Anxiety as measured via the STAI
Time frame: Monthly from baseline through study completion at 8 weeks
Changes in Sleep Disturbances as measured via the Sleep Disorders Questionnaire
Time frame: Monthly from baseline through study completion at 8 weeks
Subjective Success of Commercial Device measured via Questionnaire
Time frame: Once at the end of week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OOLER and EmbrWave in people with Sleep Quality, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nocturnal Heart Rate as measured by OURA Ring (time frame: Daily from baseline through study completion at 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.