OOLER for Sleep Quality

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Rockefeller Neuroscience Institute at West Virginia University, Morgantown, WVSleep QualityOOLER - Other
Eligibility
18 - 50
All Sexes
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Study Summary

This trial is testing how well different types of commercial devices improve sleep quality, stress recovery, and performance.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

4 Primary · 17 Secondary · Reporting Duration: Daily from baseline through study completion at 8 weeks

Week 8
Change in Nocturnal Heart Rate Variability as measured by OURA Ring
Change in Nocturnal Heart Rate as measured by OURA Ring
Change in Sleep Quantity as measured by EEG
Change in Subjective Sleep Quality measured via Questionnaire
Week 8
Changes in Conflict Management via Questionnaire
Changes in Emotional Regulation as measured via ERQ
Changes in Sleep Disturbances as measured via the Sleep Disorders Questionnaire
Changes in Subjective Anxiety as measured via the STAI
Changes in Subjective Sleep as measured via PSQI
Week 8
Change in Mental Rotation via Computer Task
Week 1
Subjective Sleep Preferences measured via Questionnaire
Week 8
Subjective Success of Commercial Device measured via Questionnaire
Week 8
Changes in Perceived Stress as measured via PSS
Week 8
Change in Attentional Vigilance via Mackworth Clock Task
Change in Cognitive Performance via Stroop Task
Change in Response Inhibition via SART 2
Week 8
Change in Subjective Athens Insomnia Scale measured via Questionnaire
Change in Subjective Epworth Sleepiness Scale measured via Questionnaire
Change in Subjective Insomnia Severity Index measured via Questionnaire
Change in Subjective Patient Reported Outcomes Measurement Information System measured via Questionnaire
Change in Subjective Restorative Sleep Questionnaire

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Flotation therapy sensory deprivation tank
1
Simulated Flotation Therapy
1
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Trial Design

2 Treatment Groups

OOLER
1 of 2
EmbrWave
1 of 2

Active Control

52 Total Participants · 2 Treatment Groups

Primary Treatment: OOLER · No Placebo Group · N/A

OOLER
Other
ActiveComparator Group · 1 Intervention: OOLER · Intervention Types: Other
EmbrWave
Other
ActiveComparator Group · 1 Intervention: EmbrWave · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: daily from baseline through study completion at 8 weeks

Who is running the clinical trial?

West Virginia UniversityLead Sponsor
161 Previous Clinical Trials
50,379 Total Patients Enrolled

Eligibility Criteria

Age 18 - 50 · All Participants · 1 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
West Virginia100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Rockefeller Neuroscience Institute at West Virginia University100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

Are individuals under 25 years of age admissible for this research?

"According to the eligibility requirements, individuals aged 18-50 are suitable for this trial. There is a separate clinical investigation ongoing for minors and another one specifically tailored towards seniors above 65 years of age." - Anonymous Online Contributor

Unverified Answer

Are new participants being recruited for this exploration currently?

"Affirmative. Clinicaltrials.gov has information which indicates that this clinical trial is presently enrolling individuals, with the initial posting being made on October 18th 2021 and last updated February 8th 2022. The study requires 80 patients to be recruited from one medical site." - Anonymous Online Contributor

Unverified Answer

What envisioned outcomes is this clinical trial hoping to attain?

"This 8-week trial will closely track participants' nocturnal heart rate variability using the OURA Ring. Secondary objectives include assessing restorative sleep through a 9-item questionnaire, measuring difficulty to fall asleep via an 8-item survey, and enquiring into subjective satisfaction with their assigned device at study completion." - Anonymous Online Contributor

Unverified Answer

Who is eligible to participate in this research initiative?

"Patients between 18 and 50 years old who are struggling with their sleeping quality can apply to join this clinical trial. A total of 80 volunteers are sought for the study." - Anonymous Online Contributor

Unverified Answer

How many participants is the trial recruiting?

"Yes, according to clinicaltrials.gov the study is actively recruiting patients with recruitment beginning on October 18th 2021 and updated February 8th 2022. This trial seeks 80 participants at one site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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