StressNCT04381182
Heart Rate Variability and Stress Management Enhancement
A study testing Apollo Wearable Device in people with Stress and Heart Rate Variability, run by Joseph Maroon at 1 site in United States.
Trial summary
This study will be conducted by using two devices (Apollo and Biostrap) for monitoring of baseline physiologic variables and heart rate variability. The biostrap will be worn by residents and will monitor heart rate, heart rate variability, respiratory rate, sleep patterns, steps, etc. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress, Heart Rate Variability
- What is being tested?
- Apollo Wearable Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 20 Aug 2022
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Neurosurgical Resident (UPMC)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Presbyterian Hospital Department of Neurological Surgery
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Impact of Heart Rate Variability Modulation on Stress and Performance Among Neurosurgical Residents
This study will be conducted by using two devices (Apollo and Biostrap) for monitoring of baseline physiologic variables and heart rate variability. The biostrap will be worn by residents and will monitor heart rate, heart rate variability, respiratory rate, sleep patterns, steps, etc. The Apollo is a pulse generator device aimed at modulating heart rate variability for (hopefully) reduction in stress and improving performance in and around the hospital. Resident neurosurgeons will wear the biostrap for a two week cycle and follow that with the addition of the Apollo device for heart rate variability modulation.
- Conditions
- Stress, Heart Rate Variability
- Being tested
- Apollo Wearable Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apollo Wearable DeviceDevice
Participants wear Apollo device which generates vibration frequencies on skin and can be controlled by the user
| Study group | Role | What they receive |
|---|---|---|
| Biostrap/Apollo Device Use | Other | Participants wear a Biostrap wearable device which measures steps, heart rate, heart rate variability, sleep metrics, and quantitative data in typical day-to-day activities of residents. Participants then again wear Biostrap except now also with the Apollo device which is worn around the ankle and is suggested to modulate heart rate variability and perceived stress of participants. Receives: Device: Apollo Wearable Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to two month heart rate variability
Quantitative (average range, beats per minute)
Measured: Baseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time point
Change from baseline to two month Perceived Stress Scale
Questionnaire, 14 point form/scale ranging from 0-50 with higher scores signifiying increased stress
Measured: Baseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time point
Change from baseline to two month Quick Inventory of Depressive Symptomatology (QIDS)
Questionnaire ranging from 0-27 and measuring major depressive symptomatology. Higher scores signify more severe depression.
Measured: Baseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start1 Sep 2021
- Primary completion20 Jul 2022
- Study completion20 Aug 2022
Why it stopped: Insufficient data/adherence
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph Maroon
- Sponsor type
- University, hospital or other
- Collaborators
- Apollo Neuro
- Responsible party
- Sponsor-investigator, Joseph Maroon, University of Pittsburgh
- Investigators
- Joseph Maroon, Principal investigator, Department of Neurological Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381182
- Sponsor's protocol ID
- STUDY19020291
- Status last verified
- Dec 2022
- First submitted
- 5 May 2020
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified changes in heart rate variability, de-identified changes between QIDS and PSS questionnaires.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Heart Rate Variability Modulation on Stress and Performance Among Neurosurgical Residents
- ClinicalTrials.gov ID
- NCT04381182
- Acronym / sponsor ID
- STUDY19020291
- Conditions
- Stress, Heart Rate Variability
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient data/adherence
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Joseph MaroonUniversity, hospital or other
- Collaborators
- Apollo Neuro
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Aug 2022 (actual)
- First posted
- 8 May 2020 (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.
This study will be conducted by using two devices (Apollo and Biostrap) for monitoring of baseline physiologic variables and heart rate variability. The biostrap will be worn by residents and will monitor heart rate, heart rate variability, respiratory rate, sleep patterns, steps, etc. The Apollo is a pulse generator device aimed at modulating heart rate variability for (hopefully) reduction in stress and improving performance in and around the hospital. Resident neurosurgeons will wear the biostrap for a two week cycle and follow that with the addition of the Apollo device for heart rate variability modulation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biostrap/Apollo Device Use | Other | Device: Apollo Wearable DeviceParticipants wear a Biostrap wearable device which measures steps, heart rate, heart rate variability, sleep metrics, and quantitative data in typical day-to-day activities of residents. Participants then again wear Biostrap except now also with the Apollo device which is worn around the ankle and is suggested to modulate heart rate variability and perceived stress of participants. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Neurosurgical Resident (UPMC)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apollo Wearable DeviceParticipants wear Apollo device which generates vibration frequencies on skin and can be controlled by the user | Device | Biostrap/Apollo Device Use |
Primary outcome
Change from baseline to two month heart rate variability
Time frame: Baseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time point
Quantitative (average range, beats per minute)
Change from baseline to two month Perceived Stress Scale
Time frame: Baseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time point
Questionnaire, 14 point form/scale ranging from 0-50 with higher scores signifiying increased stress
Change from baseline to two month Quick Inventory of Depressive Symptomatology (QIDS)
Time frame: Baseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time point
Questionnaire ranging from 0-27 and measuring major depressive symptomatology. Higher scores signify more severe depression.
Results and safety
The study was stopped early (reason given: Insufficient data/adherence). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Individual participant dataSharing planned: Yes. De-identified changes in heart rate variability, de-identified changes between QIDS and PSS questionnaires.
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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.
Joseph Maroon principal investigator
Department of Neurological Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apollo Wearable Device in people with Stress and Heart Rate Variability, run by Joseph Maroon 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 1 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: stopped early, as of the sponsor's last update on 6 Dec 2022. 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 stopped early (reason given: Insufficient data/adherence). Results are not available in the source record.
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?
Change from baseline to two month heart rate variability (time frame: Baseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time point). The study lists 3 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 6 Dec 2022; AzTrials last refreshed its copy on 6 Nov 2026.