Evaluating the Impact of Home-Based Sleep Apnea Diagnostic on Well-Being, Health Behavior, and AF Load in Patients With Atrial Fibrillation Using a Decentralized Platform

NCT06618417 | Recruiting

• 1 other identifier: 2023-12410
• Study Type: interventional
• Target: 936
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to find out if testing for sleep apnea (a condition where breathing stops and starts during sleep) at home can improve well-being in people with atrial fibrillation (an irregular heartbeat condition). About 936 participants will be involved. They will either be tested for sleep apnea and treated, if needed, or not tested at all. Researchers will compare the well-being and heart-related symptoms of participants who are tested for sleep apnea to those who are not. These will be tracked using a mobile app to monitor symptoms, physical activity, and heart rhythm. Main hypothesis: Participants with atrial fibrillation who are tested and possibly treated for sleep apnea will have improved quality of life scores (measured by the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire) by at least 5 points after 18 weeks.

Conditions

Atrial Fibrillation (AF); Sleep Apnea

Keywords

atrial fibrillation; decentralized; sleep apnea home-evaluation; randomized; digital health; quality of life

Outcome Measures

Primary Outcomes (1)

• Quality of Life

  The primary outcome is the Atrial Fibrillation Effect on Quality-Of-Life (AFEQT) questionnaire, which scores from 0 (worst) to 100 (best), based on 20 questions using a seven-point Likert scale.

  18 weeks

Secondary Outcomes (3)

• AF load

  18 weeks

• Physical health behavior

  18 weeks

• Symptom severity

  18 weeks

Other Outcomes (4)

• Hospitalization and ablation

  5 years

• Sleep quality

  18 weeks

• Quality of Life - Long-term follow up

  One year

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention will be sleep apnea home-evaluation

Device: sleep apnea home-evaluation

Control

NO INTERVENTION

This arm will not undergo sleep apnea home-evaluation

Interventions

sleep apnea home-evaluation DEVICE

Participants will receive a home-monitoring device by mail to test for sleep apnea at home

Also known as: sleep apnea diagnostics

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Established paroxysmal or persistent AF diagnosis
• Owning a compatible smartphone
• years or older

You may not qualify if:

• Previous investigation for sleep-disturbed breathing
• Advanced heart failure (left ventricular dysfunction and NYHA III/IV)
• Occupational driver licenses
• Pregnancy
• Doxazosin or Terazosin treatment (alpha-adrenergic antagonists)
• Peripheral arterial disease with daily intermittent claudication

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead

Study Sites (1)

Herlev-Gentofte Hospital

Hellerup, 2900, Denmark

RECRUITING

Related Publications (15)

• Fein AS, Shvilkin A, Shah D, Haffajee CI, Das S, Kumar K, Kramer DB, Zimetbaum PJ, Buxton AE, Josephson ME, Anter E. Treatment of obstructive sleep apnea reduces the risk of atrial fibrillation recurrence after catheter ablation. J Am Coll Cardiol. 2013 Jul 23;62(4):300-5. doi: 10.1016/j.jacc.2013.03.052. Epub 2013 Apr 23.

  PMID: 23623910 BACKGROUND

• Linz D, McEvoy RD, Cowie MR, Somers VK, Nattel S, Levy P, Kalman JM, Sanders P. Associations of Obstructive Sleep Apnea With Atrial Fibrillation and Continuous Positive Airway Pressure Treatment: A Review. JAMA Cardiol. 2018 Jun 1;3(6):532-540. doi: 10.1001/jamacardio.2018.0095.

  PMID: 29541763 BACKGROUND

• Mehra R, Chung MK, Olshansky B, Dobrev D, Jackson CL, Kundel V, Linz D, Redeker NS, Redline S, Sanders P, Somers VK; American Heart Association Electrocardiography and Arrhythmias Committee of the Council on Clinical Cardiology; and Stroke Council. Sleep-Disordered Breathing and Cardiac Arrhythmias in Adults: Mechanistic Insights and Clinical Implications: A Scientific Statement From the American Heart Association. Circulation. 2022 Aug 30;146(9):e119-e136. doi: 10.1161/CIR.0000000000001082. Epub 2022 Aug 1.

  PMID: 35912643 BACKGROUND

• Verhaert DVM, Betz K, Gawalko M, Hermans ANL, Pluymaekers NAHA, van der Velden RMJ, Philippens S, Vorstermans B, Simons SO, den Uijl DW, Chaldoupi SM, Luermans JGLM, Westra SW, Lankveld T, Kadhim K, Pepin JL, van Steenwijk RP, Hol B, Schotten U, Sanders P, Vernooy K, Hendriks JM, Linz D. A VIRTUAL Sleep Apnoea management pathway For the work-up of Atrial fibrillation patients in a digital Remote Infrastructure: VIRTUAL-SAFARI. Europace. 2022 Apr 5;24(4):565-575. doi: 10.1093/europace/euab229.

  PMID: 34718525 BACKGROUND

• Spertus J, Dorian P, Bubien R, Lewis S, Godejohn D, Reynolds MR, Lakkireddy DR, Wimmer AP, Bhandari A, Burk C. Development and validation of the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire in patients with atrial fibrillation. Circ Arrhythm Electrophysiol. 2011 Feb;4(1):15-25. doi: 10.1161/CIRCEP.110.958033. Epub 2010 Dec 15.

  PMID: 21160035 BACKGROUND

• Neilan TG, Farhad H, Dodson JA, Shah RV, Abbasi SA, Bakker JP, Michaud GF, van der Geest R, Blankstein R, Steigner M, John RM, Jerosch-Herold M, Malhotra A, Kwong RY. Effect of sleep apnea and continuous positive airway pressure on cardiac structure and recurrence of atrial fibrillation. J Am Heart Assoc. 2013 Nov 25;2(6):e000421. doi: 10.1161/JAHA.113.000421.

  PMID: 24275628 BACKGROUND

• Patel D, Mohanty P, Di Biase L, Shaheen M, Lewis WR, Quan K, Cummings JE, Wang P, Al-Ahmad A, Venkatraman P, Nashawati E, Lakkireddy D, Schweikert R, Horton R, Sanchez J, Gallinghouse J, Hao S, Beheiry S, Cardinal DS, Zagrodzky J, Canby R, Bailey S, Burkhardt JD, Natale A. Safety and efficacy of pulmonary vein antral isolation in patients with obstructive sleep apnea: the impact of continuous positive airway pressure. Circ Arrhythm Electrophysiol. 2010 Oct;3(5):445-51. doi: 10.1161/CIRCEP.109.858381. Epub 2010 Aug 5.

  PMID: 20689107 BACKGROUND

• Kanagala R, Murali NS, Friedman PA, Ammash NM, Gersh BJ, Ballman KV, Shamsuzzaman AS, Somers VK. Obstructive sleep apnea and the recurrence of atrial fibrillation. Circulation. 2003 May 27;107(20):2589-94. doi: 10.1161/01.CIR.0000068337.25994.21. Epub 2003 May 12.

  PMID: 12743002 BACKGROUND

• Abumuamar AM, Dorian P, Newman D, Shapiro CM. The prevalence of obstructive sleep apnea in patients with atrial fibrillation. Clin Cardiol. 2018 May;41(5):601-607. doi: 10.1002/clc.22933. Epub 2018 May 10.

  PMID: 29745973 BACKGROUND

• Shamsuzzaman AS, Gersh BJ, Somers VK. Obstructive sleep apnea: implications for cardiac and vascular disease. JAMA. 2003 Oct 8;290(14):1906-14. doi: 10.1001/jama.290.14.1906.

  PMID: 14532320 BACKGROUND

• Corrigendum to: 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2021 Feb 1;42(5):507. doi: 10.1093/eurheartj/ehaa798. No abstract available.

  PMID: 33029625 BACKGROUND

• Jons C, Hansen PS, Johannessen A, Hindricks G, Raatikainen P, Kongstad O, Walfridsson H, Pehrson S, Almroth H, Hartikainen J, Petersen AK, Mortensen LS, Nielsen JC; MANTRA-PAF Investigators. The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) trial: clinical rationale, study design, and implementation. Europace. 2009 Jul;11(7):917-23. doi: 10.1093/europace/eup122. Epub 2009 May 15.

  PMID: 19447807 BACKGROUND

• Kayser L, Karnoe A, Furstrand D, Batterham R, Christensen KB, Elsworth G, Osborne RH. A Multidimensional Tool Based on the eHealth Literacy Framework: Development and Initial Validity Testing of the eHealth Literacy Questionnaire (eHLQ). J Med Internet Res. 2018 Feb 12;20(2):e36. doi: 10.2196/jmir.8371.

  PMID: 29434011 BACKGROUND

• Lip GYH. The ABC pathway: an integrated approach to improve AF management. Nat Rev Cardiol. 2017 Nov;14(11):627-628. doi: 10.1038/nrcardio.2017.153. Epub 2017 Sep 29. No abstract available.

  PMID: 28960189 BACKGROUND

• Isabelle C Van Gelder, Michiel Rienstra, Karina V Bunting, Ruben Casado-Arroyo, Valeria Caso, Harry J G M Crijns, Tom J R De Potter, Jeremy Dwight, Luigina Guasti, Thorsten Hanke, Tiny Jaarsma, Maddalena Lettino, Maja-Lisa Løchen, R Thomas Lumbers, Bart Maesen, Inge Mølgaard, Giuseppe M C Rosano, Prashanthan Sanders, Renate B Schnabel, Piotr Suwalski, Emma Svennberg, Juan Tamargo, Otilia Tica, Vassil Traykov, Stylianos Tzeis, Dipak Kotecha, ESC Scientific Document Group , 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): Developed by the task force for the management of atrial fibrillation of the European Society of Cardiology (ESC), with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Endorsed by the European Stroke Organisation (ESO), European Heart Journal, 2024;, ehae176, https://doi.org/10.1093/eurheartj/ehae176

  BACKGROUND

Related Links

• Danish Health Authority

MeSH Terms

Conditions

Atrial Fibrillation; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Morten Kjøbek Lamberts ML Associate Professor Lamberts

CONTACT

+45 22434186; morten.kjoebek.lamberts@regionh.dk

Mads Hashiba Jensen Hashiba, MD

CONTACT

+45 28779403; mads.hashiba.jensen.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: October 1, 2024
• Study Start: December 5, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)