Post-acute COVID-19 SyndromeSENSING-AINCT06247332
SENSING-AI in Patients With Long COVID (SENSING-AI)
An observational study of Post-acute COVID-19 Syndrome, run by Adhera Health, Inc. at 1 site in Spain.
Trial summary
The retrospective study will be used to develop an artificial intelligence model of risk stratification of physiological and psychological complications arising from the information available in the electronic medical record and first consultation report to support patients and healthcare professionals in better… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-acute COVID-19 Syndrome
- What is being tested?
- Review of available clinical data sources related to use cases
- How many people
- 103 participants
- Where
- 1 siteSpain
- Study dates
- 18 Jan 2022to 25 Feb 2022
- 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: The sample size for the retrospective study enough to generate a first version of the risk stratification models will be around 100 cases. The target population will be as balanced as possible between subjects who needed specialized care due to long COVID-19 complications (either specialized care consultations or any non-planned hospital admission) at 1 month, 3 months, 6 months and 1 year from the long COVID-19 diagnose and those who did not require such specialized care.
Who may be able to join
- Legal adult
- Diagnosed of long COVID-19 in the last year
- With the presence of any of these symptoms:
- Asthenia (Tiredness)
- Dyspnea
- Shortness of breath
Show all 10Show fewer
- Anxiety
- Stress
- Depression
- Sleep disorder
Who cannot join
- Attended to specialized care consultation
- Was admitted in hospital in the last year due to a problem not related to the COVID complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Data Collection for SENSING-AI: a Wearable Platform for the Early Diagnosis of Emotional Disorders and Exacerbations in Patients With Long COVID Through the Use of Artificial Intelligence
The retrospective study will be used to develop an artificial intelligence model of risk stratification of physiological and psychological complications arising from the information available in the electronic medical record and first consultation report to support patients and healthcare professionals in better managing the healthcare process for patients diagnosed with long COVID.
Read the detailed description
The stratification of the risk of complications related to persistent COVID both physiological and psychological in a personalized way would optimize the cost-effectiveness model for the management of these patients. Similarly, the early detection of complications associated with persistent COVID in patients belonging to vulnerable groups would improve care times and, therefore, the patient's prognosis.
The primary objective for this study is to gather anonymized retrospective data of patients suffering from long COVID in order to contribute to the generation of the SENSING-AI cohort.
- Conditions
- Post-acute COVID-19 Syndrome
- Being tested
- Review of available clinical data sources related to use cases
- Keywords
- Long COVID-19, Retrospective study, Artificial Intelligence, Mental Health
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Review of available clinical data sources related to use casesOther
There will be a review of available clinical data sources related to use cases. In addition, this information will be complemented by a cohort of anonymized retrospective data of 100 cases obtained from the clinical information resulting from the assistance to COVID-19 patients managed by the Primary Care Health District of Sevilla Norte and the Infectious Diseases Department of the Virgen Macarena University Hospital
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Long COVID cases | The target population will be as balanced as possible between subjects who needed specialized care due to long COVID-19 complications (either specialized care consultations or any non-planned hospital admission) at 1 month, 3 months, 6 months and 1 year from the long COVID-19 diagnose and those who did not require such specialized care. Receives: Other: Review of available clinical data sources related to use cases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective SENSING-AI cohort
The retrospective SENSING-AI cohort will be fed from clinical information of 100 cases of patients with long COVID-19.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start18 Jan 2022
- Primary completion25 Feb 2022
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-acute COVID-19 SyndromeStudies 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
- Retrospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adhera Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Virgen Macarena
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247332
- Sponsor's protocol ID
- SEN-0121
- Acronym
- SENSING-AI
- Status last verified
- Feb 2024
- First submitted
- 31 Jan 2024
- Last updated
- 18 Feb 2025
- 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 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Data Collection for SENSING-AI: a Wearable Platform for the Early Diagnosis of Emotional Disorders and Exacerbations in Patients With Long COVID Through the Use of Artificial Intelligence
- ClinicalTrials.gov ID
- NCT06247332
- Acronym / sponsor ID
- SENSING-AI / SEN-0121
- Conditions
- Post-acute COVID-19 Syndrome
- Keywords
- Long COVID-19, Retrospective study, Artificial Intelligence, Mental Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Adhera Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Virgen Macarena
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 7 Feb 2024 (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 retrospective study will be used to develop an artificial intelligence model of risk stratification of physiological and psychological complications arising from the information available in the electronic medical record and first consultation report to support patients and healthcare professionals in better managing the healthcare process for patients diagnosed with long COVID.
Detailed description
The stratification of the risk of complications related to persistent COVID both physiological and psychological in a personalized way would optimize the cost-effectiveness model for the management of these patients. Similarly, the early detection of complications associated with persistent COVID in patients belonging to vulnerable groups would improve care times and, therefore, the patient's prognosis.
The primary objective for this study is to gather anonymized retrospective data of patients suffering from long COVID in order to contribute to the generation of the SENSING-AI cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective Long COVID cases | – | Other: Review of available clinical data sources related to use casesThe target population will be as balanced as possible between subjects who needed specialized care due to long COVID-19 complications (either specialized care consultations or any non-planned hospital admission) at 1 month, 3 months, 6 months and 1 year from the long COVID-19 diagnose and those who did not require such specialized care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample size for the retrospective study enough to generate a first version of the risk stratification models will be around 100 cases. The target population will be as balanced as possible between subjects who needed specialized care due to long COVID-19 complications (either specialized care consultations or any non-planned hospital admission) at 1 month, 3 months, 6 months and 1 year from the long COVID-19 diagnose and those who did not require such specialized care.
Key inclusion criteria (10 listed)
- Legal adult
- Diagnosed of long COVID-19 in the last year
- With the presence of any of these symptoms:
- Asthenia (Tiredness)
- Dyspnea
Key exclusion criteria (2 listed)
- Attended to specialized care consultation
- Was admitted in hospital in the last year due to a problem not related to the COVID complications
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 |
|---|---|---|
| Review of available clinical data sources related to use casesThere will be a review of available clinical data sources related to use cases. In addition, this information will be complemented by a cohort of anonymized retrospective data of 100 cases obtained from the clinical information resulting from the assistance to COVID-19 patients managed by the Primary Care Health District of Sevilla Norte and the Infectious Diseases Department of the Virgen Macarena University Hospital | Other | Retrospective Long COVID cases |
Primary outcome
Retrospective SENSING-AI cohort
Time frame: 1 month
The retrospective SENSING-AI cohort will be fed from clinical information of 100 cases of patients with long COVID-19.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID-19 Syndrome, run by Adhera Health, Inc. at 1 site in Spain.
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 10 inclusion and 2 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: finished, as of the sponsor's last update on 18 Feb 2025. 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 Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Retrospective SENSING-AI cohort (time frame: 1 month). 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 18 Feb 2025.