Apollo Remote Observational Sleep Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Sleep Quality; Heart Rate

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • Apollo Neuroscience, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Current Apollo Neuro customers who own and use Oura ring devices

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Inability to complete questionnaires written in English.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Apollo Neuroscience, Inc.
• Investigators: Principal Investigator: David Rabin, MD PHD, Apollo Neuroscience, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: sleep quality, HRV, tvs, wearable
• Other Study ID Numbers: AN001; 20214102 (Other Identifier: WCG IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No