{"type":"trials","record":{"id":46751,"source_id":"clinicaltrials-gov","external_id":"NCT04715555","title":"A Study of the Acceptability and Performance of Wearables for Atrial Fibrillation Screening in Older Adults","brief_summary":"\\--- Background and study aim Atrial fibrillation (AF) is an irregular heart rhythm which causes a five-fold increase in the risk of stroke. Approximately one in ten people aged over 70 have AF. If AF is recognised then the risk of stroke can be reduced by taking tablets regularly. AF can be difficult to recognise as it can occur without symptoms and only intermittently. Consequently, AF is not recognised in many people, meaning they live with an increased risk of stroke. Therefore, it is important to find ways to identify AF more reliably. Recently, wearable devices have been developed which could be useful for identifying AF. Several devices can monitor heart activity in daily life, including wristbands, smart watches and chest patch monitors. The aim of this study is to assess the acceptability and performance of wearables for use in AF screening in older adults. The primary objective is to determine the feasibility of measuring inter-beat-intervals using a wristband. The secondary objectives are: (i) to determine the acceptability of wearables; (ii) to determine the acceptability of the screening approach; (iii) to assess the performance of wearables for acquiring signals; (iv) to assess the performance of signal processing algorithms; and (v) to assess the performance of wearables for AF screening. \\--- Who can participate? Selected people who have previously participated in the SAFER Programme can participate in this study. The Investigators will invite previous SAFER Programme participants to also participate in this study, aiming to enrol 65 without AF, and 65 with AF. \\--- What does the study involve? Participants will be asked to wear three devices for seven days: Two wristbands (like watches), and one chest patch (like a plaster). These devices will collect measurements of their heart's activity. The Investigators will also ask participants to tell them how they found wearing the devices by completing a questionnaire. The Investigators will compare how participants found wearing each device, and how accurately each device identifies AF. \\--- What are the possible benefits and risks of participating? There will be no direct benefit to participants, although this research is intended to benefit future patients like them. Some participants may experience irritation or redness whilst wearing a chest patch - participants will be advised that if this occurs then they should remove it straightaway.","overall_status":"Active Not Recruiting","phases":[],"study_type":"OBSERVATIONAL","sponsor":"University of Cambridge","enrollment":130,"countries":["United Kingdom"],"start_date":"2023-02-02","completion_date":"2025-05-23","last_update_date":"2025-04-08","source_url":"https://clinicaltrials.gov/study/NCT04715555","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Active Not Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:30:23.925947+00:00","last_seen_at":"2026-09-25T03:15:46.32+00:00","metadata":{"acronym":null,"organization":"University of Cambridge","source_has_results":false},"controlled_terms":["Atrial Fibrillation","Paroxysmal Atrial Fibrillation","Electrocardiogram monitoring","Electrocardiogram recording","Photoplethysmogram monitoring","Feedback questionnaire"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: wearable.","quality_checked_at":"2026-09-25T03:15:49.327669+00:00","duplicate_cluster_key":"id:nct04715555","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2023-02-02 to 2025-05-23","comparator":null,"confidence":"structured-source","population":null,"provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T03:38:00.457301+00:00","intervention":[],"participants":130,"study_design":"OBSERVATIONAL","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":[],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"digital-biomarkers","is_published":true,"match_reasons":["Title contains controlled term: wearable.","Abstract contains controlled term: wearable.","Title supplies longevity context: older adult.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Digital biomarkers","slug":"digital-biomarkers"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/46751","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}