Clinical trial NCT06097442: Effect of Apollo Wearable on Long COVID-19 Symptoms.
Official title: Effect of Apollo Wearable on Symptoms Related to Post-acute Sequelae SARS-CoV-2 Infection (PASC).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post-acute Sequelae of SARS-COV-2 Infection
Keywords: long-COVID
Apollo
Lead sponsor: The Board of Medicine
Sponsor class: OTHER
Collaborators: name: Apollo Neuroscience, Inc.
First posted: 2023-10-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Existing or new customers of Apollo Neuro wellness device

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Post-Covid-19 Functional Status Scale (PCFS)
timeFrame: Monthly for 6 months
Secondary outcomes:
measure: Modified Medical Research Council (mMRC) Dyspnea Scale
timeFrame: Monthly for 6 months
measure: EuroQol-5D-5L (EQ-5D)
timeFrame: Monthly for 6 months
measure: Neurobehavioral Symptom Inventory (NSI)
timeFrame: Monthly for 6 months
measure: Fatigue Severity Scale (FSS)
timeFrame: Monthly for 6 months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Monthly for 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: The Board of Medicine
state: Pennsylvania
Study officials:
References: