Apollo Remote Observational Sleep Study

NCT ID: NCT05260489

Last Updated: 2024-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-18

Study Completion Date

2025-10-01

Brief Summary

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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

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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.

Conditions

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Sleep Quality Heart Rate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Inability to complete questionnaires written in English.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Apollo Neuroscience, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Rabin, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Apollo Neuroscience, Inc.

Locations

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Apollo Neuroscience, Inc.

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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20214102

Identifier Type: OTHER

Identifier Source: secondary_id

AN001

Identifier Type: -

Identifier Source: org_study_id

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