Guidance
3 Committee considerations
The evidence
3.1 NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 2 sources, which was discussed by the committee. The evidence included 1 single-arm clinical trial (3 papers) and 1 pilot study. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview. The committee also considered additional confidential documentation provided by a company.
3.2 The professional experts and the committee considered the key efficacy outcomes to be: adherence, improvement in sleep apnoea, reduction in snoring and improvement in quality of life (of the person with obstructive sleep apnoea and their bed partner).
3.3 The professional experts and the committee considered the key safety outcomes to be: pain and tingling or unpleasant sensation in the mouth.