RPMO2 Oximeter Accuracy During Sleep 1 Trial

Monitoring of physiologic variables indicative of the presence and status of chronic disease have proven to be of considerable value in the clinical management and improvement of therapeutic outcomes. For instance, positive airway pressure (PAP) devices used in the treatment of obstructive sleep apnea (OSA) and pulmonary diseases provide nightly monitoring of therapeutic pressures and pulmonary disturbances. Sleep-related declines in the oxyhemoglobin saturation of arterial blood (SaO2) are a common and important pathophysiological occurrence and are associated with cardiovascular incidences and decreased survival in patients with sleep apnea. As well, such nocturnal hypoxia displays substantial night-to-night variability in respiratory status during sleep. Thus, the need for a comfortable, accurate oximeter capable of multi-night monitoring seems undeniable. Nonetheless, standard pulse oximeters are not commonly used for multi-night monitoring of SaO2 as the currently available devices are cumbersome and disturb sleep. An important consideration is that nightly monitoring must be convenient and inexpensive, features not present in currently available oximeters. The accuracy of conventional oximeters can be compromised by factors such as movement, poor perfusion, impaired thermoregulation, and ambient light interference. Importantly, SpO2 readings have been shown to be overestimated in individuals with darker skin, potentially leading to increased incidence of occult hypoxemia.

ProSomnus Sleep Technologies (Pleasanton, CA, USA) has developed a novel buccal mucosal oximeter (RPMO2 OSA Device). The oximeter is encapsulated in an overlay of the maxillary dentition and uses the mucosa of the buccal vestibule behind the upper lip as the reflective tissue. This device is suitable for long-term nightly monitoring as it is comfortable and rechargeable. Additionally, the site of the oximeter sensor, the buccal mucosa, has the advantages of being highly vascular, relatively void of melanin, and protected from ambient light. The device has been validated in a controlled desaturation study per ISO 80601-2-61, in which arterial blood samples from healthy, awake volunteers were collected and analyzed using co-oximetry while volunteers were desaturated from ~97% to ~72% SaO2. The RPMO2 device met the accuracy requirements stipulated by the United Stated Food and Drug Administration for reflectance pulse oximeters, i.e., ARMS ± 3.5% for SpO2 and ARMS ± 3bpm for pulse rate.

The purpose of the present investigation is to validate the accuracy of the RPMO2 device in adults with OSA during sleep versus the gold standard, in-lab polysomnography.

Inclusion criteria

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18 years or older
• Diagnosed with obstructive sleep apnea (per American Academy of Sleep Medicine's definition)
• Adequate dentition for oral appliance therapy
• Ability to refrain from the use of OSA therapy other than the study device for the week prior to the in-lab sleep study

Exclusion criteria

• Non-respiratory sleep disorders or environmental or personal factors that preclude the accuracy, acquisition, or interpretation of in-lab polysomnography
• Pregnancy
• In the opinion of the principal investigator, unsuitable for participation in the study