Soft-palate implants for simple snoring (interventional procedures consultation)
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional Procedure Consultation Document
Soft-palate implants for simple snoring
|Snoring is a breathing disturbance that occurs during sleep. Although not always problematic, it can disturb sleep and affect relationships with others. The noise of snoring is produced by vibration of soft tissues in the mouth or throat and, in some people, also the soft palate (part of the roof of the mouth). Small pieces of synthetic fibre can be implanted into the soft palate, with the aim of making it stiffer and less likely to vibrate.|
The National Institute for Health and Clinical Excellence is examining soft-palate implants for simple snoring and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. The Institute'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 soft-palate implants for simple snoring.
Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.
The process that the Institute will follow after the consultation period ends is as follows.
For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprogrammemanual).
Closing date for comments: 21 August 2007
|Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.|
|1.1||Current evidence on soft-palate implants for simple snoring raises no major safety concerns. However, the evidence on efficacy is based on small case series only and there is a lack of well-controlled and comparative data. Therefore, this procedure should only be used in the context of research.|
|1.2||Further research should include explicit details of patient selection, and both clinical and quality of life outcomes.|
|2.1.1||This guidance relates to patients who snore, but who do not experience apnoea (temporary suspension of breathing) or hypopnoea episodes (abnormally slow or shallow respiration). NICE is developing Interventional Procedures guidance on the use of soft palate implants for obstructive sleep apnoea (see section 3.1). Snoring is caused by the vibration of soft pharyngeal structures during sleep which, in some patients, include the soft palate. Snoring may disturb the sleep of the patient and their bed partner, and affect relationships.|
|2.1.2||Snoring may be improved by lifestyle changes such as weight loss, smoking cessation, changes in sleeping position and avoidance of alcohol or sleeping tablets. A variety of surgical interventions have been used for snoring, including injection snoreplasty (injection of a sclerosant into the soft palate), radiofrequency ablation of the soft palate, laser-assisted uvulopalatoplasty, uvulopalatopharyngoplasty, cautery-assisted palatal stiffening and soft-palate implants.|
|2.2||Outline of the procedure|
|2.2.1||Under local anaesthesia, a hollow introducer needle containing the implant is used to pierce the soft palate close to the junction with the hard palate, into its muscle layer. The needle is then withdrawn, leaving the implant in position. Mirror examination or nasal endoscopy may be used to check that the implant has not penetrated the nasal surface of the soft palate. Typically, two or three implants are inserted in a single procedure, at the midline of the soft palate or parallel to it. The implants may be removed with forceps if necessary. The aim of the procedure is to stiffen the soft palate over subsequent weeks as a result of fibrosis.|
|2.3.1||Snoring intensity was used as an outcome measure in a number of the studies. This involved assessment by the patient's bed partner using a scale (usually 0-10) ranging from no snoring to snoring that caused the partner to leave the room. A randomised controlled trial (RCT) reported that mean scores decreased from 7.7 at baseline to 4.7 at 90 days follow-up (p < 0.01) in 10 patients with standard implants, compared with a decrease from 8.1 to 6.1 (not significant) in 10 patients with more rigid implants. In two case series, mean snoring intensity scores decreased from 7.6 and 8.5 at baseline, to 3.7 and 5.0 at 90 days follow-up and 4.0 and 4.4 at 1 year follow-up respectively (n = 99, values estimated from a diagram, p value not reported; n = 25, p < 0.001 vs baseline).|
|2.3.2||Three case series combined patients with simple snoring and those with obstructive sleep apnoea (OSA) in their analyses. Mean snoring intensity scores at baseline, 90 days and 1-year follow-up were 7.1, 4.2 and 4.8, respectively (p < 0.05 vs baseline) in the first case series of 32 patients. In the second case series of 34 patients, the scores were 7.1, 3.4 and 4.8 respectively (p < 0.001 vs baseline). Mean snoring loudness scores in the third case series of 12 patients, measured on a scale from 0 to 100, were 79 at baseline and 48 at 90 days follow-up (n = 9, p = 0.008).|
|2.3.3||Reported baseline daytime tiredness (measured using the Epworth sleepiness scale [ESS]), based on patient-reported scores ranging from 0 [best] to 24 [worst]) were 8.0 and 8.3 at baseline in two case series. The scores decreased to 7.3 at 90 days follow-up (n = 21, not significant) and 5.2 at 1 year follow-up (n = 99, values estimated from a diagram, p < 0.0001), respectively. Three case series including patients with OSA and simple snoring reported decreases in mean ESS scores from baseline 8.9 to 5.7 at 3 month follow-up (n = 9, p = 0.007), 6.1 to 4.9 at 1 year follow-up (n = 40, p < 0.05 vs baseline), and 9.3 to 5.6 at 1 year follow-up (n = 34, p < 0.001). For more details, refer to the sources of evidence (see appendix).|
|2.3.4||The Specialist Advisers identified key efficacy outcomes as snoring intensity, daytime sleepiness, satisfaction and quality of life in both patients and bed partners. One noted that it is difficult to document long-term benefits. Another noted that outcome measures are rarely validated, ranging from sound level estimate to patient and partners' satisfaction scores.|
|2.4.1||Four case series of 99, 25, 40 and 12 patients reported no postoperative infections.|
|2.4.2||Partial extrusion rates of 4% to 25% in patients were reported in five case series with follow-up ranging from 71 days to 1 year (number not stated, n = 25, n = 40, n = 34, n = 12). An RCT of 20 patients reported extrusion of 40% (4/10) rigid implants but 0% (0/10) of standard rigidity implants at 6 months follow-up.|
|2.4.3||Studies reported pain scores, using a scale from 0 (no pain) to 10 (extreme pain), which ranged from 4.9 at 2 day follow-up to 0.2 at 90 day follow-up.|
|2.4.4||The RCT of 20 patients and the two case series of 99 and 40 patients did not report any severe adverse events following the procedure. For more details, refer to the sources of evidence (see appendix).|
|2.4.5||The Specialist Advisers considered that potential adverse events include sepsis, local infection, migration/extrusion of implants, ?foreign body' sensation, bleeding, pain, minor scarring and a compromise of continuous positive airway pressure.|
|3.1||The Institute has issued Interventional Procedures guidance on radiofrequency ablation of the soft palate for snoring (ipg124) and is developing IP guidance on soft-palate implants for obstructive sleep apnoea (/proxy/?sourceUrl=http%3a%2f%2fwww.nice.org.uk%2fIP_404).|
Chairman, Interventional Procedures Advisory Committee
|Appendix:||Sources of evidence|
The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.
Available from: www.nice.org.uk/ip388overview.
This page was last updated: 30 March 2010