NCT02349893

Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Olympus Surgical Technologies Europe · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The United States is currently experiencing an increase in the incidence and prevalence of obstructive sleep apnea (OSA). With prevalence in middle-aged adults of 2 to 4% of the population, untreated OSA has been implicated in increased risk for cardiovascular disease, including hypertension and heart failure, daytime sleepiness, and increased risk of motor vehicle accidents. This study was design in order to evaluate the CelonProSleep plus for multi-level radiofrequency ablation (RFA) of the palate and base of tongue as a treatment for mild to moderate obstructive sleep apnea syndrome (OSAS).

Conditions

• Apnea, Sleep

Interventions

Type	Name	Description
DEVICE	RFA treatment	RFA treatment using CelonProSleep plus system

Timeline

• Start date: 2015-02-01
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2015-01-29
• Last updated: 2022-07-19
• Results posted: 2022-07-19

Locations

6 sites across 1 country: United States