Clinical trial at the NHS Royal Free Hospital (UK)
Compared AcuPebble SA100 to at-home multi-channel polygraphy followed by sleep specialist manual signal interpretation, the current ambulatory gold standard (powered sample of 150 patients). This trial proved:
- Equivalence to current ambulatory gold standard for sleep apnoea detection based on AHI and ODI with 3% and 4% desaturation criteria (94% PPV, 98% NPV).
- AcuPebble can be used at home, with 100% of patients able to complete the test without training or assistance.
- Results published in the BMJ Open.