Interventional procedure consultation document

Radiofrequency ablation of the soft palate for snoring

Treating snoring by using radiofrequency energy to shrink and stiffen the roof of the mouth

Snoring can be caused by vibration of the soft palate in the roof of the mouth. In this procedure, radiofrequency heat energy is used to scar the soft palate, which stiffens it and may reduce the vibrations that create the snoring sound.

The National Institute for Health and Care Excellence (NICE) is examining radiofrequency ablation of the soft palate for snoring and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of specialist advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about radiofrequency ablation of the soft palate for snoring.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the provisional recommendations
• the identification of factual inaccuracies
• additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website.

Through its guidance NICE is committed to promoting race and disability equality, equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.

In order to help us promote equality through our guidance, we should be grateful if you would consider the following question:

Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations between people with a characteristic protected by the equalities legislation and others?

Please note that NICE reserves the right to summarise and edit comments received during consultations or not to publish them at all where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 22 July 2013

Target date for publication of guidance: November 2013

1                      Provisional recommendations

1.1                  Current evidence suggests that there are no major safety concerns associated with radiofrequency ablation (RFA) of the soft palate for snoring. The evidence on the short-term efficacy of the procedure is adequate, although uncertainties remain about its efficacy in the longer term. Therefore this procedure may be used with normal arrangements for clinical governance, consent and audit.

1.2                  During the consent process clinicians should, in particular, inform patients of the uncertainty about the procedure’s long-term efficacy and of the possible need for further procedures if symptoms recur.

1.3                  Patient selection is important: the sound of snoring can arise from several different levels in the upper airway and this procedure should only be used for patients whose snoring has been shown to be caused by abnormal movement of the soft palate.

1.4                  NICE encourages further research into RFA of the soft palate for snoring. This could take the form of data collection, with the specific aim of documenting long-term outcomes and the need for further treatment.

2                      Indications and current treatments

2.1                  Snoring is a noisy inspiratory sound produced by vibration and partial airway obstruction in the pharynx. One cause is vibration of the soft palate. It can lead to disrupted sleep, daytime tiredness and poor concentration – both for the person who snores and anyone sleeping close by.  Snoring can be associated with obstructive or central sleep apnoea.

2.2            Conservative treatments involve lifestyle changes, including weight loss, avoiding alcohol and sedatives, stopping smoking and sleep position training. Physical appliances (such as dental or oral devices) have also been used to maintain normal airflow dynamics during sleep. Procedures available for pharyngeal airway obstruction include laser-assisted uvulopalatoplasty (LAUP) and uvulopalatopharyngoplasty (UPPP).

3                      The procedure

3.1                  Radiofrequency ablation (RFA) aims to stiffen the soft palate. It may be combined with other techniques (such as removal of uvula or tonsillectomy) to reduce airflow obstructions and vibration in the airway.

3.2                  The patient usually has the procedure as an outpatient and it is carried out using local anaesthesia. An electrode delivery device is introduced into the mouth and directed upwards towards the soft palate. A needle tip makes a series of very shallow punctures in the underlying muscle. Radiofrequency energy is delivered at each puncture site, commonly in the mid-portion of the palate from the uvular base to the posterior nasal spine. Alternatively, two lateral applications can be given at a lower energy setting and to several areas on either side. The intention is to scar and tighten the soft palate. If necessary the procedure can be repeated several weeks after the first: it is often carried out 2 or 3 times.

4                      Efficacy

This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.

4.1                  A randomised controlled trial of 23 patients comparing radiofrequency ablation (RFA) (n=12) against a sham procedure (n=11) showed a significant improvement in snoring scores (assessed by bed partner using a 10‑point visual analogue scale; 0: no snoring, 10: excessive snoring prompting bed partner to leave the room) for the RFA group at 6 to 8-week follow-up, compared against the sham group. The mean score decreased from 8 to 5 in the RFA group and from 8.4 to 8.0 in the sham group (p<0.05 for difference between groups). However, only 2 out of 12 patients in the RFA group had a score below 3 (defined as the criterion for success).

4.2                  In the randomised controlled trial of 23 patients, daytime sleepiness (assessed using the Epworth Sleepiness Scale; lower scores indicating a better outcome) at 6 to 8‑week follow-up decreased from 5 before the procedure to 4 after the procedure in the RFA group, and from 5 to 4 in the sham group. The difference between the 2 groups was not statistically significant (p=0.77).

4.3                  A case series of 52 patients measured quality of life using a questionnaire with fixed responses. Thirty-nine per cent (20/52) of patients reported a ‘great’ improvement, 19% (10/52) reported a ‘moderate’ improvement, 25% (13/52) reported a ‘mild’ improvement and 17% (9/52) reported ‘no improvement’. The mean quality-of-life score improved from 4 to 9 (p<0.05) at mean follow up of 7 months (details on the scale not reported).

4.4                  In a case series of 29 patients, 25% of patients (numbers not reported) reported satisfaction with the outcome 3 to 4 years after the procedure. Further treatment was carried out in 28% (8/29) of patients (4 had mandibular advancement devices, 1 had continuous positive airway pressure and 3 had radiofrequency-assisted uvulopalatoplasty).

4.5                  The specialist advisers listed the following key efficacy outcomes: improvement in snoring and upper airway obstruction leading to resolution of daytime sleepiness and improved quality of life for patient and partner.

5                      Safety

This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.

5.1                  Bleeding was reported in 2 patients in a case series of 218 patients. One patient developed a submucosal haematoma of the soft palate (timing unclear) associated with haemorrhage that needed haemostasis (no further details). Another patient had bleeding after their third radiofrequency ablation (RFA) treatment (19 days after the procedure), which was treated by bipolar coagulation.

5.2                  Airway oedema (timing unclear) needing treatment with corticosteroids was reported in 5% (2/40) of patients after RFA in a non-randomised comparative study of 70 patients comparing RFA against injection snoreplasty.

5.3                  Swelling of the uvula (1 day after the procedure) needing hospital admission (no further details) was reported in 1 patient in the case series of 218 patients.

5.4                  Mild to moderate mucosal erosion (timing unclear) was reported in 48% (10/23) of patients in a case series of 23 patients.

5.5                  Infection of the soft palate was reported in 6 patients after the procedure in the case series of 218 patients (timing unclear; treated by oral antibiotics). One patient went on to develop a peritonsillar abscess that needed surgical drainage.

5.6                  Ulceration at the RFA probe insertion sites were reported in 5 patients in the case series of 29 patients. All ulcers healed within ‘a couple of weeks’.

5.7                  The specialist advisers listed perforation of palate and palatal fistula as anecdotal adverse events. They also said that a theoretical adverse event was regurgitation due to palatal insufficiency.

6                      Further information

6.1                  This guidance is a review of ‘Radiofrequency ablation of the soft palate for snoring’ NICE interventional procedure guidance 124 (2005).

6.2                  For related NICE guidance see the NICE website.

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

June 2013