Clinical trial NCT05260489: Apollo Remote Observational Sleep Study
Official title: Apollo Remote Observational Sleep Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sleep Quality
Heart Rate
Keywords: sleep quality, HRV, tvs, wearable
Lead sponsor: Apollo Neuroscience, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Current Apollo Neuro customers who own and use Oura ring devices

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.

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.

Primary outcomes:
measure: Average Heart Rate during sleep
timeFrame: Through study completion, an average of 4 years
measure: Heart Rate Variability during sleep
timeFrame: Through study completion, an average of 4 years
measure: Lowest Heart Rate during sleep
timeFrame: Through study completion, an average of 4 years
measure: Sleep Onset
timeFrame: Through study completion, an average of 4 years
measure: Sleep efficiency
timeFrame: Through study completion, an average of 4 years
measure: Wake time during sleep
timeFrame: Through study completion, an average of 4 years
measure: Sleep duration
timeFrame: Through study completion, an average of 4 years
measure: Deep sleep duration
timeFrame: Through study completion, an average of 4 years
measure: REM sleep duration
timeFrame: Through study completion, an average of 4 years
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Through study completion, an average of 4 years
Secondary outcomes:
measure: Oura Sleep Score
timeFrame: Through study completion, an average of 4 years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Apollo Neuroscience, Inc.
state: Pennsylvania
Study officials:
affiliation: Apollo Neuroscience, Inc.
name: David Rabin, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: