Sleep QualityNCT05260489
Apollo Remote Observational Sleep Study
An observational study of Sleep Quality and Heart Rate, run by Apollo Neuroscience, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Heart Rate
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2022to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Current Apollo Neuro customers who own and use Oura ring devices
Who may be able to join
- Aged 18 or more
- Use both the Apollo wearable and Oura ring
Who cannot join
- Inability to complete questionnaires written in English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Apollo Neuroscience, Inc.
Pittsburgh, Pennsylvania, 15219
About this study
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.
Read the 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.
- Conditions
- Sleep Quality, Heart Rate
- Keywords
- sleep quality, HRV, tvs, wearable
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Heart Rate during sleep
The average heart rate measured during sleep in beats per minute
Measured: Through study completion, an average of 4 years
Heart Rate Variability during sleep
The Heart Rate Variability value measured during sleep in milli seconds
Measured: Through study completion, an average of 4 years
Lowest Heart Rate during sleep
The lowest Heart Rate measured during sleep in beats per minutes
Measured: Through study completion, an average of 4 years
Sleep Onset
The amount of time it takes to fall asleep once you are on the bed in seconds
Measured: Through study completion, an average of 4 years
Sleep efficiency
The proportion of time spent sleeping to total time in bed
Measured: Through study completion, an average of 4 years
Wake time during sleep
Total amount of time spent awake during a sleep session in seconds
Measured: Through study completion, an average of 4 years
Sleep duration
Total amount of time spent sleeping in seconds
Measured: Through study completion, an average of 4 years
Deep sleep duration
Total amount of time spent in deep sleep during sleep sessions in seconds
Measured: Through study completion, an average of 4 years
REM sleep duration
Total amount of time spent in REM sleep during sleep sessions in seconds
Measured: Through study completion, an average of 4 years
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.
Measured: Through study completion, an average of 4 years
Secondary outcomes (1)
Oura Sleep Score
A proprietary Oura score (0-100) assigned to daily sleep based on sleep quality, age, gender, and sleep metrics.
Measured: Through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start18 Jan 2022
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Why it stopped: A similar dataset was being collected in another internal study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apollo Neuroscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Rabin, MD PHD, Principal investigator, Apollo Neuroscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260489
- Sponsor's protocol ID
- AN001
- Other IDs
- 20214102
- Status last verified
- Jul 2024
- First submitted
- 10 Feb 2022
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apollo Remote Observational Sleep Study
- ClinicalTrials.gov ID
- NCT05260489
- Acronym / sponsor ID
- AN001
- Conditions
- Sleep Quality, Heart Rate
- Keywords
- sleep quality, HRV, tvs, wearable
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: A similar dataset was being collected in another internal study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Apollo Neuroscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Current Apollo Neuro customers who own and use Oura ring devices
Key inclusion criteria (2 listed)
- Aged 18 or more
- Use both the Apollo wearable and Oura ring
Key exclusion criteria (1 listed)
- Inability to complete questionnaires written in English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Oura Sleep Score
Time frame: Through study completion, an average of 4 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Rabin, MD PHD principal investigator
Apollo Neuroscience, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Quality and Heart Rate, run by Apollo Neuroscience, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Heart Rate during sleep (time frame: Through study completion, an average of 4 years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024; AzTrials last refreshed its copy on 2 Nov 2026.