Fire needle for the moderate obstructive sleep apnea hypopnea ayndrome(OSAHS): study protocol for a multicenter randomized controlled trial

Abstract Background Obstructive sleep apnea hypopnea syndrome (OSAHS) is considered to be greatly harmful due to its high incidence and low awareness rate, and has a considerable adverse impact on quality of life (QoL) for patients and their cohabitants. Our previous pilot trial suggested that fire needle might be a potential treatment option for OSAHS. We will conduct this trial to assess the efficacy and safety of fire needle for the moderate OSAHS. Methods/design A total of 102 eligible patients will be randomly allocated to either the fire needle group or the sham acupuncture group. Each patient will receive 16 sessions over eight weeks. The primary outcome is apnea hypopnea index (AHI). Secondary outcomes includes oxygen desaturation index (ODI)and other polysomnography (PSG) monitoring indicators, scores of Pittsburgh sleep quality index (PSQI) questionnaires, scores of Epworth sleepiness (ESS) scale questionnaires and visual analogue scores (VAS) of the patient's snoring by cohabitants. All patients who receive randomization will be included in the intent-to-treat analysis. Discussion The finding of this trial will provide high-quality evidence on the efficacy of fire needle for treating moderate OSAHS. According to the result, we will establish a fire needle treatment scheme for moderate OSAHS. Results of this research will be published in peer-reviewed journals. Trial registration: Chinese Clinical Trail Registry, ChiCTR2300067509. Registered on 10 Jan 2023.