1. In this randomized controlled trial, the combination of an eye mask sleep position device and oral appliance therapy was significantly more effective than either treatment alone for improving apnea-hypopnea index (AHI) in positional obstructive sleep apnea (OSA).
2. The combination therapy was also associated with higher rates of effective treatment at 6 months compared to either intervention alone.
Evidence Rating Level: 1 (Excellent)
Obstructive sleep apnea (OSA) is a sleep-breathing disorder linked to serious cardiac complications, public safety risks, and higher all-cause mortality. While continuous positive airway pressure (CPAP) is the first-line treatment for OSA, compliance is often poor. A new sleep position therapy device (SPT) featuring an eye mask and blood oxygen monitor, as well as oral appliance therapy (OAT), offer alternative therapies, particularly for those whose OSA is linked to their sleeping position. Therefore, the purpose of the present study was to assess the effectiveness of the combination of SPT and OAT versus either device alone in treating positional OSA.
This randomized controlled trial was conducted at a sleep center in China between May 2019 and December 2020. Out of 312 patients screened, 60 individuals were randomly assigned to the SPT, OAT, or combined intervention groups (n=20 per group). Participants were included if they were between the ages of 18 and 80 years old and exhibited at least one of the following: snored more than 5 days a week with complaints of daytime sleepiness, had at least two other signs or symptoms of OSA, or had a diagnosis of positional OSA with an apnea-hypopnea index (AHI) of over 5 events per hour. Exclusion criteria included severe health conditions that would prevent participation, various dental conditions, latex allergies, and pregnancy. Participants underwent follow-ups at 1 and 6 months following the start of treatment. The primary outcome was a decline in AHI after 6 months. Secondary outcomes included changes in oxygen-derived parameters and curative effect at 6 months, measured by polysomnography.
The results showed that the combined use of SPT and OAT was significantly more effective than either device alone in reducing AHI. The combination therapy was also associated with the highest rates of effective treatment at 6 months. A limitation of the study was that it was conducted in a single center with a small sample size and a low representation of women, limiting its generalizability. Nonetheless, the randomized controlled trial suggested that the combined use of both SPT and OAT offered additional benefits to either treatment alone in treating OSA.
Click to read the study in Sleep Medicine
Image: PD
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