Apollo Remote Observational Sleep Study

• ClinicalTrials.gov Identifier: NCT05260489
• Recruitment Status: Enrolling by invitation
• First Posted: March 2, 2022
• Last Update Posted: February 10, 2023
• Sponsor: Apollo Neuroscience, Inc.
• Information provided by (Responsible Party): Apollo Neuroscience, Inc.

Study Description

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.

Condition or disease
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 Design

• Study Type: Observational
• Estimated Enrollment: 6000 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Apollo Remote Observational Sleep Study
• Actual Study Start Date: January 18, 2022
• Estimated Primary Completion Date: August 1, 2025
• Estimated Study Completion Date: October 1, 2025

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Average Heart Rate during sleep [ Time Frame: Through study completion, an average of 4 years ]
   The average heart rate measured during sleep in beats per minute
2. Heart Rate Variability during sleep [ Time Frame: Through study completion, an average of 4 years ]
   The Heart Rate Variability value measured during sleep in milli seconds
3. Lowest Heart Rate during sleep [ Time Frame: Through study completion, an average of 4 years ]
   The lowest Heart Rate measured during sleep in beats per minutes
4. Sleep Onset [ Time Frame: 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
5. Sleep efficiency [ Time Frame: Through study completion, an average of 4 years ]
   The proportion of time spent sleeping to total time in bed
6. Wake time during sleep [ Time Frame: Through study completion, an average of 4 years ]
   Total amount of time spent awake during a sleep session in seconds
7. Sleep duration [ Time Frame: Through study completion, an average of 4 years ]
   Total amount of time spent sleeping in seconds
8. Deep sleep duration [ Time Frame: Through study completion, an average of 4 years ]
   Total amount of time spent in deep sleep during sleep sessions in seconds
9. REM sleep duration [ Time Frame: Through study completion, an average of 4 years ]
   Total amount of time spent in REM sleep during sleep sessions in seconds
10. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 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.

Secondary Outcome Measures :

1. Oura Sleep Score [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Current Apollo Neuro customers who own and use Oura ring devices

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Inability to complete questionnaires written in English.

Contacts and Locations

Locations

United States, Pennsylvania

Apollo Neuroscience, Inc.

Pittsburgh, Pennsylvania, United States, 15219

Sponsors and Collaborators

Apollo Neuroscience, Inc.

Investigators

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

More Information

• Responsible Party: Apollo Neuroscience, Inc.
• ClinicalTrials.gov Identifier: NCT05260489
• Other Study ID Numbers: AN001; 20214102 ( Other Identifier: WCG IRB )
• First Posted: March 2, 2022
• Last Update Posted: February 10, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Apollo Neuroscience, Inc.:

sleep quality, HRV, tvs, wearable