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Apollo Remote Observational Sleep Study

Apollo Remote Observational Sleep Study

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05260489
Enrollment
0
Registered
2022-03-02
Start date
2022-01-18
Completion date
2025-10-01
Last updated
2024-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Rate, Sleep Quality

Keywords

sleep quality, HRV, tvs, wearable

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.

Interventions

None listed

Sponsors

Apollo Neuroscience, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Inability to complete questionnaires written in English.

Design outcomes

Primary

MeasureTime frameDescription
Pittsburgh Sleep Quality Index (PSQI)Through study completion, an average of 4 yearsThe 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.
Average Heart Rate during sleepThrough study completion, an average of 4 yearsThe average heart rate measured during sleep in beats per minute
Heart Rate Variability during sleepThrough study completion, an average of 4 yearsThe Heart Rate Variability value measured during sleep in milli seconds
Lowest Heart Rate during sleepThrough study completion, an average of 4 yearsThe lowest Heart Rate measured during sleep in beats per minutes
Sleep OnsetThrough study completion, an average of 4 yearsThe amount of time it takes to fall asleep once you are on the bed in seconds
Sleep efficiencyThrough study completion, an average of 4 yearsThe proportion of time spent sleeping to total time in bed
Wake time during sleepThrough study completion, an average of 4 yearsTotal amount of time spent awake during a sleep session in seconds
Sleep durationThrough study completion, an average of 4 yearsTotal amount of time spent sleeping in seconds
Deep sleep durationThrough study completion, an average of 4 yearsTotal amount of time spent in deep sleep during sleep sessions in seconds
REM sleep durationThrough study completion, an average of 4 yearsTotal amount of time spent in REM sleep during sleep sessions in seconds

Secondary

MeasureTime frameDescription
Oura Sleep ScoreThrough study completion, an average of 4 yearsA proprietary Oura score (0-100) assigned to daily sleep based on sleep quality, age, gender, and sleep metrics.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026