Apollo Remote Observational Sleep Study

Withdrawn

• Conditions: Heart Rate; Sleep Quality

• Registration Number: NCT05260489
• Lead Sponsor: Apollo Neuroscience, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-01-18
• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-02-18
• Study First Posted: 2022-03-02
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09
• Primary Completion: 2025-08-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Aged 18 or more
• Use both the Apollo wearable and Oura ring

Exclusion Criteria

• Inability to complete questionnaires written in English.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep Onset	Through study completion, an average of 4 years	The amount of time it takes to fall asleep once you are on the bed in seconds
Sleep duration	Through study completion, an average of 4 years	Total amount of time spent sleeping in seconds
Deep sleep duration	Through study completion, an average of 4 years	Total amount of time spent in deep sleep during sleep sessions in seconds
Average Heart Rate during sleep	Through study completion, an average of 4 years	The average heart rate measured during sleep in beats per minute
Lowest Heart Rate during sleep	Through study completion, an average of 4 years	The lowest Heart Rate measured during sleep in beats per minutes
Heart Rate Variability during sleep	Through study completion, an average of 4 years	The Heart Rate Variability value measured during sleep in milli seconds
Wake time during sleep	Through study completion, an average of 4 years	Total amount of time spent awake during a sleep session in seconds
Pittsburgh Sleep Quality Index (PSQI)	Through study completion, an average of 4 years	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.
Sleep efficiency	Through study completion, an average of 4 years	The proportion of time spent sleeping to total time in bed
REM sleep duration	Through study completion, an average of 4 years	Total amount of time spent in REM sleep during sleep sessions in seconds

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Apollo Neuroscience, Inc.; 🇺🇸 Pittsburgh, Pennsylvania, United States