Apollo Remote Observational Sleep Study

Study Overview
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Brief Summary
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The purpose of this study is to examine how Transcutaneous Vibratory Stimulation (TVS) produced by the Apollo wearable affects sleep and cardiovascular function in a diverse real-world population of Apollo users.

Detailed Description
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The Apollo wearable is a consumer wellness device that offers a non-invasive, non-habit-forming wearable solution to improve performance and recovery under stress in children and adults by delivering gentle wave-like vibrations (Transcutaneous Vibratory Stimulation) to the body. In this observational cohort study, we will assess sleep and cardiovascular metrics measured during sleep by Oura ring in participants who use Apollo wearable device both historically (2 years in the past) as well as in the future (two years forward). Participants will not be required to make any changes to their activities of daily living or lifestyle except for the continued use of their Apollo wearable devices and answer periodic questionnaires through an online survey tool. Participant data for days with and without using the Apollo wearable will be analyzed to identify the near term and long term effects of using a TVS device on sleep and cardiovascular signatures. Environmental and confounding data will be derived from the survey data and biometrics data from the wearables.

Official Title
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Apollo Remote Observational Sleep Study

Conditions
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Sleep Quality, Heart Rate

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 or more Use both the Apollo wearable and Oura ring Exclusion Criteria: Inability to complete questionnaires written in English.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Heart Rate during sleep | The average heart rate measured during sleep in beats per minute | Through study completion, an average of 4 years | 
| Heart Rate Variability during sleep | The Heart Rate Variability value measured during sleep in milli seconds | Through study completion, an average of 4 years | 
| Lowest Heart Rate during sleep | The lowest Heart Rate measured during sleep in beats per minutes | Through study completion, an average of 4 years | 
| Sleep Onset | The amount of time it takes to fall asleep once you are on the bed in seconds | Through study completion, an average of 4 years | 
| Sleep efficiency | The proportion of time spent sleeping to total time in bed | Through study completion, an average of 4 years | 
| Wake time during sleep | Total amount of time spent awake during a sleep session in seconds | Through study completion, an average of 4 years | 
| Sleep duration | Total amount of time spent sleeping in seconds | Through study completion, an average of 4 years | 
| Deep sleep duration | Total amount of time spent in deep sleep during sleep sessions in seconds | Through study completion, an average of 4 years | 
| REM sleep duration | Total amount of time spent in REM sleep during sleep sessions in seconds | Through study completion, an average of 4 years | 
| Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. With a range of scores 1-21. | Through study completion, an average of 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oura Sleep Score | A proprietary Oura score (0-100) assigned to daily sleep based on sleep quality, age, gender, and sleep metrics. | Through study completion, an average of 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep quality, HRV, tvs, wearable