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.

Tracking Information

• First Submitted Date: February 10, 2022
• First Posted Date: March 2, 2022
• Last Update Posted Date: February 10, 2023
• Actual Study Start Date: January 18, 2022
• Estimated Primary Completion Date: August 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 18, 2022)

• 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
• 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
• 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
• 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
• Sleep efficiency [ Time Frame: Through study completion, an average of 4 years ]
  The proportion of time spent sleeping to total time in bed
• 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
• Sleep duration [ Time Frame: Through study completion, an average of 4 years ]
  Total amount of time spent sleeping in seconds
• 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
• 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
• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 18, 2022)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Apollo Remote Observational Sleep Study
• Official Title: Apollo Remote Observational Sleep Study
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Other
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Current Apollo Neuro customers who own and use Oura ring devices

Condition

• Sleep Quality
• Heart Rate

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: February 18, 2022): 6000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 1, 2025
• Estimated Primary Completion Date: August 1, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Inability to complete questionnaires written in English.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05260489
• Other Study ID Numbers: AN001; 20214102 ( Other Identifier: WCG IRB )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Apollo Neuroscience, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Apollo Neuroscience, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Apollo Neuroscience, Inc.
• Verification Date: February 2023