Arrhythmia AtrialAFIB24hNCT03507335
Atrial Fibrillation Detection: 24 Hour Study
An observational study of Arrhythmia Atrial and Stroke, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
Aims Approximately 20-25% of strokes are of cardioembolic origin, atrial fibrillation (AF) being a significant cause of cardioembolic strokes. AF is often symptomless and intermittent, making its detection a clinical challenge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia Atrial, Stroke
- What is being tested?
- chest strap and PPG-device for monitoring the rhythm
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- 9 Apr 2018to 31 Aug 2020
- 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: Study material will be collected in internal medicine emergency department of KUH
Who may be able to join
- Atrial fibrillation in 12-lead ECG and admission to hospital (n=50) Sinus rhythm in 12-lead ECG and admission to hospital (n=50)
Who cannot join
- BMI>35
- LBBB
- RBBB
- medical condition requiring immediate treatment
- serious infectious disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chest Strap and PPG-device Compared to Holter-device for Atrial Fibrillation Detection: 24 Hour Study
Aims Approximately 20-25% of strokes are of cardioembolic origin, atrial fibrillation (AF) being a significant cause of cardioembolic strokes. AF is often symptomless and intermittent, making its detection a clinical challenge. Currently the golden standard for diagnosis of AF is by 12-lead electrocardiogram (ECG) or any other ECG-strip.
The primary aim of the study is to assess the potential of chest strap as an ECG monitor especially in arrhythmia detection by cardiologist and algorithm. The secondary aim is to assess potential of photoplethysmography (PPG) based device for arrhythmia detection.
Read the detailed description
Study design:
Study design will be a prospective case-control study at Kuopio University Hospital (KUH) in Finland. Study material will be collected in internal medicine emergency department at KUH. The study design was approved by University of Eastern Finland ethics committee (347/2018).
Study participants will receive a written information sheet about the study and will be provided with an opportunity to ask questions concerning the study. A written informed consent will be signed by the participants, including a permission to use patient's medical records.
Screening of study participants will be made in participating hospitals from admitted patients in January 2018 - May 2019. The inclusion criteria for study group patients was atrial fibrillation confirmed by a doctor-interpreted 12-lead ECG . Exclusion criteria were: body mass index (BMI) over 35; implanted pacemaker device; 12-lead ECG findings of left bundle branch block (LBBB) or right bundle branch block (RBBB); medical condition requiring immediate treatment that would be delayed by the study measurements; serious infectious disease. Control group consisted of patients with normal sinus rhythm (SR) in 12-lead ECG.
Measurement
Demographics of study patients, including age, gender, previous medical history (as reported by patient or from patient medical records), length and weight , will be recorded.
Before measurements, the patient will be asked to rest for at least 2 minutes, and lay still during the measurements. First, a 12-lead ECG will taken over a period of 10 seconds for rhythm confirmation for study grouping. In the next step, altogether 5 wet electrodes will be attached to patient to record ECG with Faros 360 Holter device (Mega Elektroniikka, Kuopio, Finland) to be used as golden standard for rhythm monitoring. Simultaneously a heart rate monitoring chest strap (Suunto Movesense, Suunto, Vantaa, Finland) will applied to chest approximately 2 cm below the lower end of sternum, according to manufacturer's instructions. PPG-device (Empatica Empatica ltd, Milan, Italy) will be connected to non-dominating wrist. A total of 24 hous recording will be made. The data from heart rate chest strap will sent via Bluetooth connection to study computer; the data from Faros Holter device was recorded to device´s internal memory card and transferred to analyzing software. The data collected was anonymized and ECG data from chest strap and Holter device was analyzed using MATLAB software.
The quality of the ECG-strip will be defined as good (no or only minor artefacts), average (artefacts but QRS complex and/or P-wave identifiable) or poor (major artefacts, no identifiable QRS complex and/or P-wave) by the cardiologist. The rhythm from the ECG-strips was divided to three categories: sinus rhythm, atrial fibrillation or other/inconclusive. The cardiologists also assessed the possibility to detect P-waves from the ECG-strips with SR (yes/no).
The study population will consisted of total 200 patients. According to the initial 12-lead ECG, total 100 patients with atrial fibrillation will be collected, and control group will consist of 100 patients with normal sinus rhythm.
- Conditions
- Arrhythmia Atrial, Stroke
- Being tested
- chest strap and PPG-device for monitoring the rhythm
- Keywords
- Arrhythmia Atrial, heart rate monitoring, stroke, atrial fibrillation
- Medical subject headings
- Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest strap and PPG-device for monitoring the rhythmDevice
Also called Suunto Movesense, Suunto, Vantaa, Finland, Empatica Empatica ltd, Milan, Italy
chest strap and PPG-device for monitoring the rhythm during 24 hours for both groups (atrial fibrillation and sinus)
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation | Patients with atrial fibrillation during measurements Receives: Device: chest strap and PPG-device for monitoring the rhythm | |
| Sinus | Patients with sinus rhythm during measurements Receives: Device: chest strap and PPG-device for monitoring the rhythm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest strap data quality
Is chest strap ECG non-inferior or superior for the atrial fibrillation detection as compared to Holter recording. Measures for determining outcome; sensitivity and specificity for the atrial fibrillation detection.
Measured: 24 hours
Secondary outcomes (1)
Data quality to enable arrhythmia diagnosis
Is photoplethysmographic measurement non-inferior or superior for the atrial fibrillation detection as compared to Holter recording. Measures for determining outcome; sensitivity and specificity for the atrial fibrillation detection.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start9 Apr 2018
- Primary completion31 May 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Arrhythmia AtrialStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tero Martikainen, Kuopio University Hospital
- Investigators
- Tero J Martikainen, PhD, Study director, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507335
- Sponsor's protocol ID
- KUH507P001
- Acronym
- AFIB24h
- Status last verified
- Apr 2021
- First submitted
- 20 Dec 2017
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P, Agewall S, Camm J, Baron Esquivias G, Budts W, Carerj S, Casselman F, Coca A, De Caterina R, Deftereos S, Dobrev D, Ferro JM, Filippatos G, Fitzsimons D, Gorenek B, Guenoun M, Hohnloser SH, Kolh P, Lip GY, Manolis A, McMurray J, Ponikowski P, Rosenhek R, Ruschitzka F, Savelieva I, Sharma S, Suwalski P, Tamargo JL, Taylor CJ, Van Gelder IC, Voors AA, Windecker S, Zamorano JL, Zeppenfeld K. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Europace. 2016 Nov;18(11):1609-1678. doi: 10.1093/europace/euw295. Epub 2016 Aug 27. No abstract available.
PubMed 27567465Nemati S, Ghassemi MM, Ambai V, Isakadze N, Levantsevych O, Shah A, Clifford GD. Monitoring and detecting atrial fibrillation using wearable technology. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:3394-3397. doi: 10.1109/EMBC.2016.7591456.
PubMed 28269032Thijs V. Atrial Fibrillation Detection: Fishing for An Irregular Heartbeat Before and After Stroke. Stroke. 2017 Oct;48(10):2671-2677. doi: 10.1161/STROKEAHA.117.017083. Epub 2017 Sep 15. No abstract available.
PubMed 28916671Mairesse GH, Moran P, Van Gelder IC, Elsner C, Rosenqvist M, Mant J, Banerjee A, Gorenek B, Brachmann J, Varma N, Glotz de Lima G, Kalman J, Claes N, Lobban T, Lane D, Lip GYH, Boriani G; ESC Scientific Document Group. Screening for atrial fibrillation: a European Heart Rhythm Association (EHRA) consensus document endorsed by the Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), and Sociedad Latinoamericana de Estimulacion Cardiaca y Electrofisiologia (SOLAECE). Europace. 2017 Oct 1;19(10):1589-1623. doi: 10.1093/europace/eux177. No abstract available.
PubMed 29048522Freedman B, Camm J, Calkins H, Healey JS, Rosenqvist M, Wang J, Albert CM, Anderson CS, Antoniou S, Benjamin EJ, Boriani G, Brachmann J, Brandes A, Chao TF, Conen D, Engdahl J, Fauchier L, Fitzmaurice DA, Friberg L, Gersh BJ, Gladstone DJ, Glotzer TV, Gwynne K, Hankey GJ, Harbison J, Hillis GS, Hills MT, Kamel H, Kirchhof P, Kowey PR, Krieger D, Lee VWY, Levin LA, Lip GYH, Lobban T, Lowres N, Mairesse GH, Martinez C, Neubeck L, Orchard J, Piccini JP, Poppe K, Potpara TS, Puererfellner H, Rienstra M, Sandhu RK, Schnabel RB, Siu CW, Steinhubl S, Svendsen JH, Svennberg E, Themistoclakis S, Tieleman RG, Turakhia MP, Tveit A, Uittenbogaart SB, Van Gelder IC, Verma A, Wachter R, Yan BP; AF-Screen Collaborators. Screening for Atrial Fibrillation: A Report of the AF-SCREEN International Collaboration. Circulation. 2017 May 9;135(19):1851-1867. doi: 10.1161/CIRCULATIONAHA.116.026693.
PubMed 28483832Santala OE, Lipponen JA, Jantti H, Rissanen TT, Tarvainen MP, Laitinen TP, Laitinen TM, Castren M, Valiaho ES, Rantula OA, Naukkarinen NS, Hartikainen JEK, Halonen J, Martikainen TJ. Continuous mHealth Patch Monitoring for the Algorithm-Based Detection of Atrial Fibrillation: Feasibility and Diagnostic Accuracy Study. JMIR Cardio. 2022 Jun 21;6(1):e31230. doi: 10.2196/31230.
PubMed 35727618Santala OE, Halonen J, Martikainen S, Jantti H, Rissanen TT, Tarvainen MP, Laitinen TP, Laitinen TM, Valiaho ES, Hartikainen JEK, Martikainen TJ, Lipponen JA. Automatic Mobile Health Arrhythmia Monitoring for the Detection of Atrial Fibrillation: Prospective Feasibility, Accuracy, and User Experience Study. JMIR Mhealth Uhealth. 2021 Oct 22;9(10):e29933. doi: 10.2196/29933.
PubMed 34677135
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chest Strap and PPG-device Compared to Holter-device for Atrial Fibrillation Detection: 24 Hour Study
- ClinicalTrials.gov ID
- NCT03507335
- Acronym / sponsor ID
- AFIB24h / KUH507P001
- Conditions
- Arrhythmia Atrial, Stroke
- Keywords
- Arrhythmia Atrial, heart rate monitoring, stroke, atrial fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 25 Apr 2018 (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.
Aims Approximately 20-25% of strokes are of cardioembolic origin, atrial fibrillation (AF) being a significant cause of cardioembolic strokes. AF is often symptomless and intermittent, making its detection a clinical challenge. Currently the golden standard for diagnosis of AF is by 12-lead electrocardiogram (ECG) or any other ECG-strip.
The primary aim of the study is to assess the potential of chest strap as an ECG monitor especially in arrhythmia detection by cardiologist and algorithm. The secondary aim is to assess potential of photoplethysmography (PPG) based device for arrhythmia detection.
Detailed description
Study design:
Study design will be a prospective case-control study at Kuopio University Hospital (KUH) in Finland. Study material will be collected in internal medicine emergency department at KUH. The study design was approved by University of Eastern Finland ethics committee (347/2018).
Study participants will receive a written information sheet about the study and will be provided with an opportunity to ask questions concerning the study. A written informed consent will be signed by the participants, including a permission to use patient's medical records.
Screening of study participants will be made in participating hospitals from admitted patients in January 2018 - May 2019. The inclusion criteria for study group patients was atrial fibrillation confirmed by a doctor-interpreted 12-lead ECG . Exclusion criteria were: body mass index (BMI) over 35; implanted pacemaker device; 12-lead ECG findings of left bundle branch block (LBBB) or right bundle branch block (RBBB); medical condition requiring immediate treatment that would be delayed by the study measurements; serious infectious disease. Control group consisted of patients with normal sinus rhythm (SR) in 12-lead ECG.
Measurement
Demographics of study patients, including age, gender, previous medical history (as reported by patient or from patient medical records), length and weight , will be recorded.
Before measurements, the patient will be asked to rest for at least 2 minutes, and lay still during the measurements. First, a 12-lead ECG will taken over a period of 10 seconds for rhythm confirmation for study grouping. In the next step, altogether 5 wet electrodes will be attached to patient to record ECG with Faros 360 Holter device (Mega Elektroniikka, Kuopio, Finland) to be used as golden standard for rhythm monitoring. Simultaneously a heart rate monitoring chest strap (Suunto Movesense, Suunto, Vantaa, Finland) will applied to chest approximately 2 cm below the lower end of sternum, according to manufacturer's instructions. PPG-device (Empatica Empatica ltd, Milan, Italy) will be connected to non-dominating wrist. A total of 24 hous recording will be made. The data from heart rate chest strap will sent via Bluetooth connection to study computer; the data from Faros Holter device was recorded to device´s internal memory card and transferred to analyzing software. The data collected was anonymized and ECG data from chest strap and Holter device was analyzed using MATLAB software.
The quality of the ECG-strip will be defined as good (no or only minor artefacts), average (artefacts but QRS complex and/or P-wave identifiable) or poor (major artefacts, no identifiable QRS complex and/or P-wave) by the cardiologist. The rhythm from the ECG-strips was divided to three categories: sinus rhythm, atrial fibrillation or other/inconclusive. The cardiologists also assessed the possibility to detect P-waves from the ECG-strips with SR (yes/no).
The study population will consisted of total 200 patients. According to the initial 12-lead ECG, total 100 patients with atrial fibrillation will be collected, and control group will consist of 100 patients with normal sinus rhythm.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation | – | Device: chest strap and PPG-device for monitoring the rhythmPatients with atrial fibrillation during measurements |
| Sinus | – | Device: chest strap and PPG-device for monitoring the rhythmPatients with sinus rhythm during measurements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study material will be collected in internal medicine emergency department of KUH
Key inclusion criteria (1 listed)
- Atrial fibrillation in 12-lead ECG and admission to hospital (n=50) Sinus rhythm in 12-lead ECG and admission to hospital (n=50)
Key exclusion criteria (5 listed)
- BMI>35
- LBBB
- RBBB
- medical condition requiring immediate treatment
- serious infectious disease
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 |
|---|---|---|
| chest strap and PPG-device for monitoring the rhythmAlso: Suunto Movesense, Suunto, Vantaa, Finland, Empatica Empatica ltd, Milan, Italychest strap and PPG-device for monitoring the rhythm during 24 hours for both groups (atrial fibrillation and sinus) | Device | Atrial fibrillation, Sinus |
Primary outcome
Chest strap data quality
Time frame: 24 hours
Is chest strap ECG non-inferior or superior for the atrial fibrillation detection as compared to Holter recording. Measures for determining outcome; sensitivity and specificity for the atrial fibrillation detection.
1 secondary outcome
Data quality to enable arrhythmia diagnosis
Time frame: 24 hours
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 4 May 2021.
- Background: PubMed 27567465Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P, Agewall S, Camm J, Baron Esquivias G, Budts W, Carerj S, Casselman F, Coca A, De Caterina R, Deftereos S, Dobrev D, Ferro JM, Filippatos G, Fitzsimons D, Gorenek B, Guenoun M, Hohnloser SH, Kolh P, Lip GY, Manolis A, McMurray J, Ponikowski P, Rosenhek R, Ruschitzka F, Savelieva I, Sharma S, Suwalski P, Tamargo JL, Taylor CJ, Van Gelder IC, Voors AA, Windecker S, Zamorano JL, Zeppenfeld K. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Europace. 2016 Nov;18(11):1609-1678. doi: 10.1093/europace/euw295. Epub 2016 Aug 27. No abstract available.
- Background: PubMed 28269032Nemati S, Ghassemi MM, Ambai V, Isakadze N, Levantsevych O, Shah A, Clifford GD. Monitoring and detecting atrial fibrillation using wearable technology. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:3394-3397. doi: 10.1109/EMBC.2016.7591456.
- Background: PubMed 28916671Thijs V. Atrial Fibrillation Detection: Fishing for An Irregular Heartbeat Before and After Stroke. Stroke. 2017 Oct;48(10):2671-2677. doi: 10.1161/STROKEAHA.117.017083. Epub 2017 Sep 15. No abstract available.
- Background: PubMed 29048522Mairesse GH, Moran P, Van Gelder IC, Elsner C, Rosenqvist M, Mant J, Banerjee A, Gorenek B, Brachmann J, Varma N, Glotz de Lima G, Kalman J, Claes N, Lobban T, Lane D, Lip GYH, Boriani G; ESC Scientific Document Group. Screening for atrial fibrillation: a European Heart Rhythm Association (EHRA) consensus document endorsed by the Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), and Sociedad Latinoamericana de Estimulacion Cardiaca y Electrofisiologia (SOLAECE). Europace. 2017 Oct 1;19(10):1589-1623. doi: 10.1093/europace/eux177. No abstract available.
- Results publication: PubMed 28483832Freedman B, Camm J, Calkins H, Healey JS, Rosenqvist M, Wang J, Albert CM, Anderson CS, Antoniou S, Benjamin EJ, Boriani G, Brachmann J, Brandes A, Chao TF, Conen D, Engdahl J, Fauchier L, Fitzmaurice DA, Friberg L, Gersh BJ, Gladstone DJ, Glotzer TV, Gwynne K, Hankey GJ, Harbison J, Hillis GS, Hills MT, Kamel H, Kirchhof P, Kowey PR, Krieger D, Lee VWY, Levin LA, Lip GYH, Lobban T, Lowres N, Mairesse GH, Martinez C, Neubeck L, Orchard J, Piccini JP, Poppe K, Potpara TS, Puererfellner H, Rienstra M, Sandhu RK, Schnabel RB, Siu CW, Steinhubl S, Svendsen JH, Svennberg E, Themistoclakis S, Tieleman RG, Turakhia MP, Tveit A, Uittenbogaart SB, Van Gelder IC, Verma A, Wachter R, Yan BP; AF-Screen Collaborators. Screening for Atrial Fibrillation: A Report of the AF-SCREEN International Collaboration. Circulation. 2017 May 9;135(19):1851-1867. doi: 10.1161/CIRCULATIONAHA.116.026693.
- Derived from this study: PubMed 35727618Santala OE, Lipponen JA, Jantti H, Rissanen TT, Tarvainen MP, Laitinen TP, Laitinen TM, Castren M, Valiaho ES, Rantula OA, Naukkarinen NS, Hartikainen JEK, Halonen J, Martikainen TJ. Continuous mHealth Patch Monitoring for the Algorithm-Based Detection of Atrial Fibrillation: Feasibility and Diagnostic Accuracy Study. JMIR Cardio. 2022 Jun 21;6(1):e31230. doi: 10.2196/31230.
- Derived from this study: PubMed 34677135Santala OE, Halonen J, Martikainen S, Jantti H, Rissanen TT, Tarvainen MP, Laitinen TP, Laitinen TM, Valiaho ES, Hartikainen JEK, Martikainen TJ, Lipponen JA. Automatic Mobile Health Arrhythmia Monitoring for the Detection of Atrial Fibrillation: Prospective Feasibility, Accuracy, and User Experience Study. JMIR Mhealth Uhealth. 2021 Oct 22;9(10):e29933. doi: 10.2196/29933.
- 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.
Tero J Martikainen, PhD study director
Kuopio University Hospital
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 Arrhythmia Atrial and Stroke, run by Kuopio University Hospital at 1 site in Finland.
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 5 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 4 May 2021. 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 Finland. 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?
Chest strap data quality (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03507335, which also lists 7 linked publications.
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 4 May 2021.