TABLE IX.D.4.e.

Radiofrequency palatoplasty for OSA

Study	Year	LOE	Study design	Study groups	Clinical endpoints	Conclusion
Bäck et al.1724	2001	3a	Prospective, non-randomized	21 healthy men with habitual snoring for at least 1 year	Epworth Sleepiness Scale (ESS), visual analogue scale (VAS) scores of symptoms, cephalometric analysis, inflammatory laboratory parameters	RF thermal ablation of the soft palate seems to be effective for snoring and excessive daytime sleepiness.
Bäck et al.1725	2002	3a	Prospective, non-randomized	20 non-obese habitual snorers	Snoring, daytime sleepiness, soft palate dimensions on magnetic resonance imaging (MRI)	Significant changes in the soft palate dimensions and in the T1-signal intensity were seen on MRI, along with decreased snoring and daytime sleepiness, after RF palatoplasty.
Bäck et el.1739	2009	1b	Randomized single-blinded placebo-controlled	32 patients with mild OSA	Primary measures: apnea/hypopnea index (AHI), ESS, and a 36-item short-form quality-of-life (QOL) questionnaire Secondary measures: soft tissue airway parameters in cephalometric radiographs, snoring scores, and rates of adverse events	RF surgery of the soft palate is not recommended as a single-stage treatment in mild OSA. AHI did not differ between patients after RF surgery (11.0 preoperatively vs. 13.0 postoperatively) vs. placebo (12.0 preoperatively vs. 11.0 postoperatively, p = 0.63)
Bäck et al.1736	2009	1b	Systemic review	30 controlled or prospective studies of RF palatoplasty in snoring with at least 10 adults without moderate/severe OSA	ESS, AHI snoring severity, postoperative discomfort	RF surgery is a safe operative procedure, which may reduce symptoms of snoring in short-term follow-up. Of six studies reporting AHI and/or RDI, none reported significant change following RF.
Balsevičius et al.1743	2015	3a	Prospective, non-randomized	28 patients with mild/moderate OSA who underwent two sessions of RF within the interval from 6 to 8 weeks	VAS scores of symptoms, AHI, Sleep Apnea Quality of Life Index, Beck Depression Inventory – second edition (BDI-II), ESS	RF with nine lesions to the soft palate seems to be an effective and safe treatment modality associated with low morbidity in selected mild/moderate OSA. Mean AHI decreased from 13.7 ± 5.9 to 8.3 ± 4.9 (p < 0.01) and 60.7% of patients experienced an AHI reduction >50%.
Tatla et al.1735	2003	3b	Prospective, nonrandomized study	Ten patients with chronic habitual snoring or mild OSA	BMI, PSG, snoring VAS, subjective assessment of pain	RF palatoplasty has minimal morbidity, high patient acceptability, minimal analgesia requirements, and little inconvenience to patients. Decrease in AHI was not significant.
Powell et al.1723	1998	2b	Prospective nonrandomized	22 patients with sleep-disordered breathing	PSG, cephalometric radiographs, VAS scores of symptoms (pain, speech, snoring, and swallowing), and infrared thermal imaging	There was documented tissue reduction and improvement in symptoms in all patients. Apnea and hypopnea indices initially worsened in the 48–72 h immediately following treatment but decreased to pre-treatment levels by 10–12 weeks; long-term decrease was not significant.
Sher et al.1732	2001	2b	Prospective, nonrandomized multicenter study	113 patients with habitual disruptive snoring who had a respiratory disturbance index (RDI) < 15 and minimum oxygen saturation not less than 85%	VAS scores of symptoms (pain, snoring and sleep quality) and ESS	The multiple lesion RF protocol was the most successful. Temperature-controlled RF was found to be a minimally invasive, well-tolerated procedure. Mean RDI increased from 6.4 to 8.7 for the overall cohort (p < 0.0031).
Boudewyns et al.1729	2000	2b	Prospective, nonrandomized multi-center clinical study	45 non-apneic snorers	ESS, snoring index	RF ablation applied at the midline of the soft palate, with a maximum of three treatment sessions, improves snoring and ESS in the majority of patients without serious adverse events.
Hofmann et al.1741	2006	2b	Prospective clinical trial	79 patients with primary snoring or mild OSA (47: uvulopalatopharyngoplasty [UPPP]; 32: RF palatoplasty)	Subjective snoring scores and AHI	The success rate of RF surgery of the soft palate is clearly lower compared to UPPP. Snoring scores improved in both groups, while AHI and HI only improved in the UPPP group.
Holmlund et al.1737	2014	1b	Randomized controlled trial	35 men with snoring and mild/no OSA	ESS, Basic Nordic Sleep Questionnaire, AHI with home sleep study	RF soft palate has no significant effect on daytime sleepiness, snoring, or AHI 1 year after surgery.
Hukins et al.1730	2000	3b	Prospective, non- randomized	20 adults with loud habitual snoring without clinically significant OSA	VAS scores of symptoms (snoring intensity, pain, difficulty in swallowing), and changes in speech, polysomnography and lateral cephalometry	RF palatoplasty is well tolerated with very low morbidity. It is associated with subjective improvement in snoring in most patients. Change in AHI is not significant.
Birkent et al.1744	2008	3a	Prospective, non-randomized	26 habitual snorers and mild OSA patients (AHI < 10)	Acoustic evaluation made by the multidimensional Voice program	RF of the soft palate as a treatment for snoring and mild OSA does not havea significant impact on voice quality.
Hultcrantz et al.1731	2009	3b	Prospective, non-randomized	29 patients with habitual snoring; 10 of 29 patients underwent electromyography (EMG) of palatoglossal muscles	Snoring VAS, bedpartner estimated hours of sleep and EMG changes of palatoglossal muscles	RF treatment for snoring may lead to long-term improvement in one out of four cases. Pre-evaluation with EMG may predict the outcome.
Ferguson et al.1738	2001	2b	Prospective, non-randomized	47 habitual snorers without symptoms suggestive of OSA (16: single-lesion treatments, 31: multilesion treatments)	VAS scores for snoring and pain	Multilesion RF palatoplasty using higher energy levels per treatment is safe and has increased efficacy without increased complications relative to single-lesion therapy.
Blumen et al.1728	2013	4	Retrospective review	105 subjects with simple snoring or mild OSA	To determine whether snoring intensity measured after the first session of soft palate RF predicts the final treatment outcome	Snoring intensity after the first RF session helps predict the final outcome of RF-assisted stiffening of the soft palate for simple snoring.
Haraldsson et al.1745	2002	3a	Prospective, non-randomized	16 habitual snorers (all patients had an oxygen desaturation index <6)	Objective (nasal-oral ratio meter) and subjective (speech-language pathologist) speech evaluation	RF soft palate for snoring did not show any significant adverse effect on velopharyngeal function and voice quality.
Kermadec et al.1740	2014	4	Observational retrospective study	77 patients underwent soft palate RF treatment for snoring with AHI <20 (at least 3 years’ follow-up)	A postal questionnaire including snoring VAS, demographics, cardiovascular risk factors (body weight, hypertension and diabetes)	Relapse of snoring was observed in nearly all patients. Most patients did not comply with the follow-up instructions and did not seek other forms of treatment when recurrence occurred.
Stuck et al.1733	2004	2a	Systemic review	Habitual snorers and mild OSA (22 original articles published in peer-reviewed journals)	Snoring VAS and snoring index	RF surgery of the soft palate leads to a significant reduction of subjective snoring, and snoring is reduced to a tolerable level.
Stuck et al.1734	2005	1b	Randomized, placebo-controlled trial	26 patients with primary snoring (AHI < 15, BMI < 35) divided into treatment and placebo arms	Bed partner with snoring VAS	Snoring scores for the RF arm were significantly better than the placebo arm, although the reduction in snoring was only moderate.
Stuck et al.1742	2009	3a	Prospective clinical trial	19 patients with primary snoring (AHI < 15, BMI < 32) 18 months post-procedure	Questionnaire on snoring VAS, and the overall satisfaction with the procedure	A relapse in snoring can be expected in some patients after RF-assisted uvulopalatoplasty (RF-UPP).
Emery et al.1727	2000	3b	Prospective, non-randomized	43 snoring and/or mild OSA patients whose snoring intensity was bothersome to their bed partner	Safety, character of pain, and effects on speech, swallowing, and snoring severity	RF palatoplasty is well-tolerated and not painful.
Blumen et al.1726	2002	3a	Prospective, non-randomized	30 patients with simple snoring or mild OSA having soft palate obstruction	Efficacy and tolerance of RF and laser-assisted uvulopalatopharyngoplasty (LAUP)	RF was as effective as LAUP in reducing snoring in the short-term, and was better tolerated.