BiancaMed has rigorously trialled its SleepMinder in both clinical and consumer fields
Some of the key findings of the clinical validation studies:
- The correlation of SleepMinder™ respiration rate to gold-standard measurements is 97.8%
- SleepMinder™ can identify sleep/wake epochs with an 81.2% accuracy in normal adult subjects (comparable with existing motion-based methods)
- SleepMinder™ can distinguish patients with clinically significant SDB from normal subjects with an accuracy of 94% (using an AHI of 15 as cut-off). This is as good as, or better, than many multi- channel screening devices.
Sleep/Wake & Actimetry Comparison:
BiancaMed tested its product against wrist mounted actimetry and found that the results of this study indicate that the non-contact sensor may be a highly convenient alternative to wrist-actimetry as a diagnosis and screening tool for sleep studies.** Furthermore, as the non- contact sensor measures breathing modulations, it can additionally be used to screen for respiratory disturbances in sleep caused by sleep apnea and COPD.** The recordings were made in the unconstrained home environment under the supervision of Dr Monica Gonzalez of the Sleep Disorders Unit, Santander Spain
BiancaMed has been working on the development of the SleepMinder™ technology since 2004. The SleepMinder™ technology is based on measurement of patient movement using reflected radio- waves off a person’s chest. Specialized algorithms have been developed which can then translate this raw movement signal into breathing and non-respiratory movement information. The key points of validation up to now are:
- Verification of the ability of the technology to measure small movements accurately and reproducibly (through development of an automated mechanical movement test system)
- Verification of the safety of the SleepMinder™ technology through compliance with a number of international electrical safety standards for radio-frequency communications devices
- Installation of SleepMinder™ devices at multiple clinical sites (St Vincent’s Hospital, Dublin; Hospital Universitario Marques de Valdecilla, Santander, Spain; Ruhrlandklinik, Essen, Germany; Cinicnnati Children’s Hospital, Cinicinnati, USA). The devices have been used in a hospital and home setting.
- Collection of nearly 1000 nights of data using the SleepMinder™ devices
- Initial clinical abstracts on results of these pilot studies
SleepMinder’s performances are comparable to those of much more obtrusive, expensive and less scalable systems, such as portable PSG systems or those based on pulse oxymetry. As SleepMinder monitors respiratory effort it may be used to separate apnoea and hypopnoea events.