AI system
- System
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Apple Watch Sleep Apnea Notification Feature (breathing-disturbance notifications) and the ECG app
- Model
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Not assessed
- Release
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Exact release not established.
- Application developer
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Apple - Role
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The model detected elevated breathing disturbance and generated a notification.
- Configuration
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The participant used an Apple Watch Series 11 with an iPhone 15 Pro.
- Inputs and outputs
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Not assessed
- Autonomy
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Not assessed
- Workflow
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Nightly watch wear with the sleep-apnea notification feature active, plus the owner's habit of recording a watch ECG every morning and evening. A known history of paroxysmal AF that made the morning traces interpretable to his cardiologists. Access to a clinic willing to act on watch data (CPAP started without polysomnography).
- Human oversight
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Not assessed
- Relation to AI
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The notification feature's deep-learning model, described in Apple's submission to FDA, flagged elevated breathing disturbance and brought the patient to the clinic. His own morning ECG recordings, read by the authors, showed the AF paroxysms. The paper does not state separately what the ECG app's classifier reported. Clinicians chose CPAP and deferred ablation. The treating authors report the clinical episode. Apple supplies the technical description and validation in its 510(k) summary. FDA's clearance is a separate regulatory decision and does not verify this patient's benefit. [1] [2]
Benefits
- Outcome identifiers
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Not assessed
- Benefit
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Fukuoka case (Cureus, 26 May 2026): sleep-apnoea notifications prompted consultation; watch ECGs showed AF only after “elevated” breathing-disturbance nights; CPAP under way, no polysomnography.
- Category
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Improved Physical Health
- Status
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Not assessed
- Beneficiary groups
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People.
- Beneficiaries
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Not assessed
- Reach
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Not assessed
- Distribution and access
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Not assessed
- Duration
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Not assessed
- Expected?
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Yes
- Costs and harms
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Not assessed
Measurement
- Studies
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Not assessed
- Study design
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Not assessed
- Measurement
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Not assessed
- Setting and sample
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Not assessed
- Measures
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Not assessed
- Comparison
-
ambulatory monitoring and standard 12-lead ECG, which had documented no paroxysms since his retirement
- Results
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Reference: AF paroxysms were not documented by ambulatory monitoring or standard ECG. Result: AF paroxysms were detected repeatedly in the morning after notification of nocturnal “elevated” breathing disturbance, but not in the morning after nights when breathing disturbance was “not elevated”.
- Additional value from AI
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Not assessed
- Limitations
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Not assessed
- Denominators
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Not assessed
- Materials for replication
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Not assessed
Money
- Kind of value
-
Not assessed
- Amount
-
Not assessed
- Currency and prices
-
Not assessed
- Period and unit
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Not assessed
- Realization
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Not assessed
- Recipients and payers
-
Not assessed
- Gross or net
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Not assessed
- Included costs
-
Not assessed
- Comparison
-
Not assessed
- Method
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Not assessed
- Return and payback
-
Not assessed
People and places
- Participants
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Developer:
Apple. - Jurisdictions
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Benefit: Fukuoka,
Japan. Developer:
United States. - Ownership and control
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Not assessed
- Dependencies
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Not assessed
- Cross-border connections
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Not assessed
- Geopolitical implications
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Not assessed
Follow-up
- Conditions for replication
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The user completes onboarding and wears the watch during sleep, since the feature evaluates 30-day windows opportunistically. Clinicians confirm with conventional ECG and polysomnography, which the authors say the watch cannot replace and which was not done here.
- Replication attempts
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Not assessed
- Later findings
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The May 2026 report says CPAP therapy is under way and ablation will depend on its effect; no later outcome was found.
- Availability
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Not assessed
- Institutional decision
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Not assessed
- Grounds
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Not assessed
- Action and result
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Not assessed
- Success criterion
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Not assessed
Evidence
- Source numbers
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AIBD-0300-source-0001–0002
- Language
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Not assessed
- Original evidence
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Treating clinicians report the consultation and ECG findings. Apple’s FDA submission describes the notification algorithm and its validation. FDA’s clearance is a regulatory decision, not confirmation of this patient’s benefit. [1] [2]
- Access and versions
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The clinical report gives no sleep-study confirmation or treatment response and does not identify the ECG classifier’s contribution. Nightly breathing-disturbance ratings differ from the feature’s 30-day notification. Apple’s underlying training and validation records are not public. [1] [2]
- Supported findings
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Not assessed
- Evidence links
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Not assessed
- Evidence strength
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Not assessed
- Missing evidence
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Not assessed
Grades
- Assessed benefits
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People.
- Depth
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People: 1.
- Reasons
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People: A man whose AF was thought quiescent learned that paroxysms recur after disturbed-breathing nights, and he started CPAP. No confirmed sleep-apnea diagnosis and no treatment effect are reported.
- Observed or intended
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Not assessed
- Rubric
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Not assessed
- Assessor and date
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Not assessed
- Alternative assessments
-
Not assessed
Entry details
- Kind
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Not assessed
- Related entries
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Not assessed
- Field
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Healthcare (cardiology; sleep medicine). Consumer wearables.
- Purpose
-
The notification feature is built to identify patterns of breathing disturbance suggestive of moderate-to-severe sleep apnea and tell the user. The ECG app is built to record and classify single-lead rhythm. Both were used as designed.
- Stage
-
Not assessed
- Version
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SHA-256: 3c00ba05fd9e…
References
- Other identifiers
-
Not assessed
- Category mappings
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Not assessed
- Brief
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Not assessed
Sources
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Case report Independent author
Maruyama T, Hieda M, Fukata M (2026). Smartwatch-Detected Atrial Fibrillation on the Morning After a Nocturnal Sleep-Disordered Breathing Notification: A Case Report. Cureus 18(5):e109701 (PMC13301138). Case Presentation, Figure 2, Discussion, and references 12–14.
Original clinical narrative, ECGs and breathing-disturbance chart document consultation and management. Case Presentation; Figure 2; Discussion; references 12–14.
Treating clinical authors report the episode and declare no relevant support or financial relationships.
the smartwatch repeatedly detected AF paroxysms the following morning, only after the smartwatch had issued a breathing-disturbance notification during sleep.
-
Regulatory document Developer
Manufacturer specifies the deep-learning model, training and 30-day notification rule; FDA letter establishes clearance. FDA letter pp. 1–3; Apple summary pp. 2 and 5–7.
Mixed file: FDA's decision plus Apple's technical submission. The technical claims are maker-authored.
SANF includes a deep learning algorithm to identify breathing disturbances using accelerometer sensor data from Apple Watch.
Collections: Scrutiny and findings, Cross-border cases.