A multicentric validation study of a novel home sleep apnea test based on peripheral arterial tonometry.
Level 3 - non-randomized controlled study
Cross-sectional diagnostic validation study comparing an index test against a double-scored reference standard.
PubMed 35554589 · doi:10.1093/sleep/zsac028
What was done
A multicentric validation study evaluated a novel FDA-cleared peripheral arterial tonometry home sleep apnea test (PAT HSAT) in 167 participants suspected of having obstructive sleep apnea (OSA). All participants underwent simultaneous polysomnography (PSG) and PAT HSAT. PSG recordings were independently double-scored using both the 1A rule (requiring 3% desaturation or arousal) and the 1B rule (requiring 4% desaturation). The agreement between PAT HSAT and PSG in determining 4-way OSA severity categories was compared to the inter-rater agreement of double-scored PSG, with a correction applied for near-boundary apnea-hypopnea index values.
What was found
The 4-way OSA severity categorization accuracy of PAT HSAT was 70% under the 3% rule (compared to 77% inter-rater agreement for PSG) and 78% under the 4% rule (compared to 81% inter-rater agreement for PSG). Numerical values for other endpoint parameters were not reported in the abstract.
Why it matters
This study provides diagnostic accuracy data showing that a novel PAT-based sleep apnea test approaches the baseline inter-scorer agreement of gold-standard polysomnography for categorizing OSA severity.
Limits
The test was evaluated simultaneously with PSG rather than in an unmonitored home setting. Key diagnostic performance statistics such as sensitivity, specificity, and failure rates were not provided in the abstract, and results may not generalize to other PAT HSAT brands.
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