Efficacy and safety of fire needle therapy for obstructive sleep apnea-hypopnea syndrome: study protocol for a single arm clinical trial

Abstract

Background Obstructive sleep apnea hypopnea syndrome (OSAHS) is a sleep disorder characterized by repeated apnea and hypopnea while you're asleep, and the prevalence rate increases annually. Previous research revealed that the fire needle therapy for OSAHS good clinical efficacy but lacked proof from clinical trials. Therefore, we designed this single-arm clinical trial protocol to investigate the effectiveness and safety of treating OSAHS using fire needle therapy. Methods/design: 166 adult subjects with mild to moderate OSAHS, ranging in age from 18 to 70, will be included in this study. All subjects will receive fire needle therapy twice a week for 4 weeks and follow-up for 12 months. The following points will include outcome assessment: (1) baseline;(2) 4 weeks following treatment's start;(3) 3 months following treatment's start; (4) 12 months following treatment's start. The primary outcome of the trial is the AHI index, and the secondary outcomes include oxygen desaturation index(ODI), lowest nocturnal oxygen saturation (LSpO2), percentage of SaO2 < 90% in total sleep time (TS90%), apnea index (AI), hypopnea index (HI), subjective symptoms (by ESS score, TCM syndrome score). Safety assessments include vital sign monitoring, routine blood tests, routine urine tests, blood biochemistry, the skin Reaction Scale, the modified Vancouver scar score, and adverse events. Discussion This single-arm clinical registry study will provide evidence-based medical evidence for the efficacy and safety of fire needle therapy in OSAHS. Trail registration: Chinese Clinical Trial Registry, ChiCTR2100042309. Registered on January 7, 2021.