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Impact of night-to-night variability of Sleep Apnoea on Atrial Fibrillation

Determining the relationship of night-to-night sleep apnoea severity with autonomic function: Implications for daily Atrial Fibrillation (AF) burden in adults

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001291471
Enrollment
100
Registered
2025-11-20
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Atrial fibrillation (AF) is the most common chronic heart rhythm problem and controlling risk factors are pivotal in management. Obstructive Sleep Apnoea (OSA) has emerged as an independent risk factor for AF and is defined by repetitive airway obstruction during sleep which overtime gives rise to AF. Nightly autonomic dysfunction as a result of sleep apnoea is important in understanding AF. The study hopes to better understand about nightly autonomic dysfunction on daily AF burden overtime and assess whether treatment including CPAP or MAS has a direct, positive impact.

Interventions

Consecutive patients with paroxysmal atrial fibrillation will be invited to participate in this study after diagnostic sleep study confirming moderate-to-severe Obstructive Sleep Apnoea (OSA) with AHI greater than or equal to 15. Consenting participants will undergo implantable loop recorder (ILR) insertion for evaluation of Atrial Fibrillation (AF) burden. This will be inserted at local hospital or clinic by experienced cardiac electrophysiologist. It will quantify AF burden in percentage and

Consecutive patients with paroxysmal atrial fibrillation will be invited to participate in this study after diagnostic sleep study confirming moderate-to-severe Obstructive Sleep Apnoea (OSA) with AHI greater than or equal to 15. Consenting participants will undergo implantable loop recorder (ILR) insertion for evaluation of Atrial Fibrillation (AF) burden. This will be inserted at local hospital or clinic by experienced cardiac electrophysiologist. It will quantify AF burden in percentage and minutes. All participants will be monitored for 6 months with implantable loop recorder of AF burden and night to night sleep apnoea severity which will be measured for 1 month using a wearable device (SleepImage). Both data will be correlated to see if night to night sleep apnoea severity will change the subsequent day's autonomic function and AF burden. After 6 months of monitoring, all participants will undergo personalized sleep apnoea treatment either as Continuous Positive Airway Pressure (CPAP) or Mandibular Advancement Device (MAD). Autonomic function and AF burden will be compared with nightly sleep data while they are on treatment to correlate whether improvement in nightly sleep apneoa severity improves subsequent day's AF burden and autonomic function. All participants on OSA therapy will be followed up 1 month after commencing treatment to assess and optimize adherence. If participant has suboptimal adherence, they can switched to an alternative therapy as CPAP or MAS. Participants can be reviewed ongoingly as needed basis. SleepImage (SaMD) is a software as medical device worn as a ring or on fingertip during sleep. It measures autonomic function which includes: peripheral arterial tone, heart rate, oxygen saturation and respiration. It also contains actigraphy with a photoplethysmography (PPG) sensor which enables respiratory and sleep analysis. The signals (channels) are continuously sampled during sleep and analyzed with a cardiopulmonary coupling (CDC) algorithm. It is FDA-cleared device to aid clinical diagnosis of sleep disordered breathing in children, adolescents and adults. Sleep and autonomic data will be obtained daily by participants which can be viewed on their app on the phone. This will be reviewed by the research team remotely on a secure, password protected online platform. Sleep data including total sleep time, sleep stage, sleep apnoea/hypoapnoea severity (Apnoea-Hypopnea Index, AHI), heart rate variability and hypoxic burden will be recorded on nightly basis. Additionally, participants will undergo pulse oximetry for 14 days during the initial 6-month and latter 6-month of the study period utilising a standard, commonly used pulse oximeter for assessment of hypoxia pre and post treatment of OSA. It is a non-invasive device that is secured to a participants index finger with a clip.

Sponsors

Macquarie Univerisity
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Age greater or equal to 18 years old Presence of paroxysmal atrial fibrillation (AF) Moderate or Severe Obstructive Sleep Apnoea - Apnoea-Hypoapnoea index (AHI) greater or equal to 15/hr.

Exclusion criteria

Permanent/Persistent AF Life expectancy <2 years Pregnancy Reversible cause of AF (e.g. sepsis, thyrotoxicosis) Unable to consent Previous sleep apnoea therapy Predominant central apnoea.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026