OBJECTIVES: We compared the efficacy of 2 palatal surgical procedures in the treatment of patients with mild sleep-disordered breathing (SDB). STUDY DESIGN AND SETTING: We conducted a prospective, randomized, crossover surgical trial at a university hospital. METHODS:Twenty patients with mild SDB for whom conservative treatment failed were identified and consecutively enrolled into an institutional review board-approved surgical protocol. They were randomly assigned to undergo either radiofrequency ablation of the palate (RFAP) for a planned 3-stage treatment or laser-assisted uvulopalatoplasty (LAUP), also for 3 stages of treatment, using a CO(2) laser. Parameters assessed included severity of SDB (polysomnography), subjective and objective loudness of snoring (visual analog scale and SNAP recording), sleepiness (Epworth Sleepiness Scale), and anatomic changes (upper airway endoscopy), as well as demographic factors. Patients not achieving satisfactory improvement in their condition were crossed over to the alternative surgical therapy for attempted salvage. RESULTS: Seventeen of the enrolled patients have completed the protocol. Ten of these were randomized to the RFAP group, and 7 to the LAUP group. Six of the RFAP patients (60%) achieved a satisfactory resolution of their snoring, and 4 failed and were salvaged with LAUP. Six of the LAUP patients (86%) achieved a satisfactory resolution of their snoring, and 1 patient failed and was salvaged with nasal surgery. One patient who was initially cured had a relapse after 9 months and was successfully salvaged with RFA. CONCLUSION: Prospective, randomized trials of surgery for SDB are possible. Preliminary findings from the current protocol reveal a slight advantage of LAUP over RFAP but with a greater degree of discomfort postoperatively.
RCT Entities:
OBJECTIVES: We compared the efficacy of 2 palatal surgical procedures in the treatment of patients with mild sleep-disordered breathing (SDB). STUDY DESIGN AND SETTING: We conducted a prospective, randomized, crossover surgical trial at a university hospital. METHODS: Twenty patients with mild SDB for whom conservative treatment failed were identified and consecutively enrolled into an institutional review board-approved surgical protocol. They were randomly assigned to undergo either radiofrequency ablation of the palate (RFAP) for a planned 3-stage treatment or laser-assisted uvulopalatoplasty (LAUP), also for 3 stages of treatment, using a CO(2) laser. Parameters assessed included severity of SDB (polysomnography), subjective and objective loudness of snoring (visual analog scale and SNAP recording), sleepiness (Epworth Sleepiness Scale), and anatomic changes (upper airway endoscopy), as well as demographic factors. Patients not achieving satisfactory improvement in their condition were crossed over to the alternative surgical therapy for attempted salvage. RESULTS: Seventeen of the enrolled patients have completed the protocol. Ten of these were randomized to the RFAP group, and 7 to the LAUP group. Six of the RFAPpatients (60%) achieved a satisfactory resolution of their snoring, and 4 failed and were salvaged with LAUP. Six of the LAUP patients (86%) achieved a satisfactory resolution of their snoring, and 1 patient failed and was salvaged with nasal surgery. One patient who was initially cured had a relapse after 9 months and was successfully salvaged with RFA. CONCLUSION: Prospective, randomized trials of surgery for SDB are possible. Preliminary findings from the current protocol reveal a slight advantage of LAUP over RFAP but with a greater degree of discomfort postoperatively.
Authors: Alfred Dreher; Tobias Rader; Martin Patscheider; Christine Klemens; Michael Schmidt; Fiona Baker; Richard de la Chaux Journal: Eur Arch Otorhinolaryngol Date: 2008-06-24 Impact factor: 2.503