Post-acute Sequelae of SARS-COV-2 InfectionNCT06097442
Effect of Apollo Wearable on Long COVID-19 Symptoms.
An observational study of Post-acute Sequelae of SARS-COV-2 Infection, run by The Board of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to examine how Apollo wearable use impacts symptoms and quality of life following long COVID. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-acute Sequelae of SARS-COV-2 Infection
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2023to Mar 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
- No healthy volunteers
- Adult, Older adult
Study population: Existing or new customers of Apollo Neuro wellness device
Who may be able to join
- New purchasers of Apollo who haven't started using their Apollo device or previous users of Apollo who haven't used Apollo in the preceding 14 days.
- Age 18 years or over
- Currently experiencing symptoms related to long-COVID according to PASC (self report).
- Must be experiencing PASC symptoms in at least one of the following domains:
- Respiratory-related symptoms Fatigue-related symptoms Neurologic-related symptoms Psychiatric-related symptoms Sleep-related symptoms Change in quality of life/functional status
Who cannot join
- Inability to use or access a compatible Android or iOS smartphone
- Are unable to complete consent and questionnaires written in English
- Current resident of a European Union (EU) country
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Board of Medicine
Pittsburgh, Pennsylvania, 15219
Ema Perez, BS, 855-922-0057, clinical_coordinator@apolloneuro.com
Belinda Tan, MD, PhD
About this study
Official title: Effect of Apollo Wearable on Symptoms Related to Post-acute Sequelae SARS-CoV-2 Infection (PASC).
The purpose of this study is to examine how Apollo wearable use impacts symptoms and quality of life following long COVID.
Read the detailed description
Post-Acute Sequelae of SARS-CoV-2 infection (PASC), also known as long-COVID, is a syndrome that describes the persistence of symptoms or other sequelae weeks or months after initial SARS-CoV-2 infection. Limited evidence exists for effective treatments for this syndrome.
In this observational study, the investigators will examine the effects of Apollo wearable use on symptoms and quality of life related to long-COVID. The Apollo Neuroscience System (combined wearable and mobile application) offers a convenient, non-invasive, non-habit-forming wearable solution to improve performance and recovery under stress in children and adults. Our sample will be composed of new purchasers of Apollo or previous users of Apollo who haven't used Apollo in the preceding 14 days who are currently experiencing symptoms related to long-COVID according to PASC (self report).
Clinically validated survey tools will be administered upon enrollment in the study to assess baseline symptoms and quality of life. Once consented and enrolled in the study, participants will complete 7 monthly surveys for 6 months. Usage data from subjects' use of the wearable is also saved on the wearable directly and periodically uploaded to Apollo Neuroscience's secure and confidential database to be stored for analysis. Participants will first complete a screener survey to assess eligibility to participate. Demographic information and medication, substance, and treatment usage will also be collected.
Participants may choose to provide biometric data at their discretion for purposes of comparison at least 8 weeks before the study period, during the study period for 6 months, and at most 8 weeks after the study period. With regular Apollo use, the investigators expect to see an improvement in the physical, cognitive, and psychological symptoms associated with PASC. Initial analysis will compare subjects' baseline scores before Apollo use to scores during/after Apollo and the scores of subjects who used Apollo according to the study protocol and the scores of those who did not. Information gained from this study will help evaluate the use of Apollo as a potential non-invasive and accessible solution to aid in reducing long-COVID symptoms.
- Keywords
- long-COVID, Apollo
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Long-COVID Using Apollo | Participants with long-COVID symptoms who have consented to be part of this study will use an Apollo device according to a suggested schedule pre-set within their Apollo app, which participants can alter as they see fit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Covid-19 Functional Status Scale (PCFS)
Post-Covid-19 Functional Status Scale (PCFS) will be used to assess participants' functional recovery following a COVID-19 diagnosis.
Measured: Monthly for 6 months
Secondary outcomes (5)
Modified Medical Research Council (mMRC) Dyspnea Scale
The Modified Medical Research Council (mMRC) Dyspnea Scale will be used to assess dyspnea (labored breathing).
Measured: Monthly for 6 months
EuroQol-5D-5L (EQ-5D)
The EuroQol-5D-5L (EQ-5D) will measure health in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: Monthly for 6 months
Neurobehavioral Symptom Inventory (NSI)
The Neurobehavioral Symptom Inventory (NSI) will be used to assess neurobehavioral symptoms.
Measured: Monthly for 6 months
Fatigue Severity Scale (FSS)
The Fatigue Severity Scale (FSS) will be used to measure the severity of fatigue symptoms.
Measured: Monthly for 6 months
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) will be used to quantify sleep quality and disturbances over a month interval at a time.
Measured: Monthly for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start23 Oct 2023
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-acute Sequelae of SARS-COV-2 InfectionStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Board of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Apollo Neuroscience, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097442
- Sponsor's protocol ID
- BOM0001
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2023
- Last updated
- 27 Oct 2023
- 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 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Apollo Wearable on Symptoms Related to Post-acute Sequelae SARS-CoV-2 Infection (PASC).
- ClinicalTrials.gov ID
- NCT06097442
- Acronym / sponsor ID
- BOM0001
- Keywords
- long-COVID, Apollo
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Board of MedicineUniversity, hospital or other
- Collaborators
- Apollo Neuroscience, Inc.
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 24 Oct 2023 (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 Apollo wearable use impacts symptoms and quality of life following long COVID.
Detailed description
Post-Acute Sequelae of SARS-CoV-2 infection (PASC), also known as long-COVID, is a syndrome that describes the persistence of symptoms or other sequelae weeks or months after initial SARS-CoV-2 infection. Limited evidence exists for effective treatments for this syndrome.
In this observational study, the investigators will examine the effects of Apollo wearable use on symptoms and quality of life related to long-COVID. The Apollo Neuroscience System (combined wearable and mobile application) offers a convenient, non-invasive, non-habit-forming wearable solution to improve performance and recovery under stress in children and adults. Our sample will be composed of new purchasers of Apollo or previous users of Apollo who haven't used Apollo in the preceding 14 days who are currently experiencing symptoms related to long-COVID according to PASC (self report).
Clinically validated survey tools will be administered upon enrollment in the study to assess baseline symptoms and quality of life. Once consented and enrolled in the study, participants will complete 7 monthly surveys for 6 months. Usage data from subjects' use of the wearable is also saved on the wearable directly and periodically uploaded to Apollo Neuroscience's secure and confidential database to be stored for analysis. Participants will first complete a screener survey to assess eligibility to participate. Demographic information and medication, substance, and treatment usage will also be collected.
Participants may choose to provide biometric data at their discretion for purposes of comparison at least 8 weeks before the study period, during the study period for 6 months, and at most 8 weeks after the study period. With regular Apollo use, the investigators expect to see an improvement in the physical, cognitive, and psychological symptoms associated with PASC. Initial analysis will compare subjects' baseline scores before Apollo use to scores during/after Apollo and the scores of subjects who used Apollo according to the study protocol and the scores of those who did not. Information gained from this study will help evaluate the use of Apollo as a potential non-invasive and accessible solution to aid in reducing long-COVID symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Long-COVID Using Apollo | – | –Participants with long-COVID symptoms who have consented to be part of this study will use an Apollo device according to a suggested schedule pre-set within their Apollo app, which participants can alter as they see fit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Existing or new customers of Apollo Neuro wellness device
Key inclusion criteria (5 listed)
- New purchasers of Apollo who haven't started using their Apollo device or previous users of Apollo who haven't used Apollo in the preceding 14 days.
- Age 18 years or over
- Currently experiencing symptoms related to long-COVID according to PASC (self report).
- Must be experiencing PASC symptoms in at least one of the following domains:
- Respiratory-related symptoms Fatigue-related symptoms Neurologic-related symptoms Psychiatric-related symptoms Sleep-related symptoms Change in quality of life/functional status
Key exclusion criteria (3 listed)
- Inability to use or access a compatible Android or iOS smartphone
- Are unable to complete consent and questionnaires written in English
- Current resident of a European Union (EU) country
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
Post-Covid-19 Functional Status Scale (PCFS)
Time frame: Monthly for 6 months
Post-Covid-19 Functional Status Scale (PCFS) will be used to assess participants' functional recovery following a COVID-19 diagnosis.
5 secondary outcomes
Modified Medical Research Council (mMRC) Dyspnea Scale
Time frame: Monthly for 6 months
EuroQol-5D-5L (EQ-5D)
Time frame: Monthly for 6 months
Neurobehavioral Symptom Inventory (NSI)
Time frame: Monthly for 6 months
Fatigue Severity Scale (FSS)
Time frame: Monthly for 6 months
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Monthly for 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- 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.
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 Post-acute Sequelae of SARS-COV-2 Infection, run by The Board of Medicine 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Belinda Tan, MD, PhD (4129450345, belinda@theboardofmedicine.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Covid-19 Functional Status Scale (PCFS) (time frame: Monthly for 6 months). 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 27 Oct 2023.