Apollo Remote Observational Sleep Study

Sleep Quality Clinical Trial

Official title:

Apollo Remote Observational Sleep Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05260489
• Other study ID #: AN001
• Secondary ID: 20214102
• Status: Enrolling by invitation
• Start date: January 18, 2022
• Est. completion date: October 1, 2025

Study information

• Verified date: February 2023
• Source: Apollo Neuroscience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 6000
• Est. completion date: October 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 or more

• Use both the Apollo wearable and Oura ring

Exclusion Criteria:

• Inability to complete questionnaires written in English.

Related Conditions & MeSH terms

• Heart Rate
• Sleep Quality

Locations

Country	Name	City	State
United States	Apollo Neuroscience, Inc.	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Apollo Neuroscience, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Heart Rate during sleep	The average heart rate measured during sleep in beats per minute	Through study completion, an average of 4 years
Primary	Heart Rate Variability during sleep	The Heart Rate Variability value measured during sleep in milli seconds	Through study completion, an average of 4 years
Primary	Lowest Heart Rate during sleep	The lowest Heart Rate measured during sleep in beats per minutes	Through study completion, an average of 4 years
Primary	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
Primary	Sleep efficiency	The proportion of time spent sleeping to total time in bed	Through study completion, an average of 4 years
Primary	Wake time during sleep	Total amount of time spent awake during a sleep session in seconds	Through study completion, an average of 4 years
Primary	Sleep duration	Total amount of time spent sleeping in seconds	Through study completion, an average of 4 years
Primary	Deep sleep duration	Total amount of time spent in deep sleep during sleep sessions in seconds	Through study completion, an average of 4 years
Primary	REM sleep duration	Total amount of time spent in REM sleep during sleep sessions in seconds	Through study completion, an average of 4 years
Primary	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	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