Efficacy of Intra-oral Neuromuscular Stimulation Training on Snoring and Mild Sleep Apnoea

Summary

Participation Requirements

Description

Study Design: This phase IV prospective, observational multi-centre post-market surveillance study is proposed to run up to a period of 6 months. Five centres will be used in the trial with 20-50 trial participants per site. Each site will follow the pre-determined study protocol, collecting endpoin...

Study Design: This phase IV prospective, observational multi-centre post-market surveillance study is proposed to run up to a period of 6 months. Five centres will be used in the trial with 20-50 trial participants per site. Each site will follow the pre-determined study protocol, collecting endpoint relevant data which will then be analysed according to the methods outlined in this statistical analysis plan (SAP). In brief, participants will proceed through three phases of the trial. The pre-trial phase collects data on the pre therapy state of the participant, after which they will enter the therapy phase where they use the device once daily for the required period whilst continuing to record the required data. The participant will stop using the device at the end of this stage and have a follow up phase during which trial indices will continue to be recorded. Study procedures Screening and Eligibility Assessment Participants will be identified from Ear, Nose and Throat (ENT)-departments. The ENT-specialist identified the patients with an AHI of 5 -15/h confirmed by polysomnography during the standard visit in which the results of the polysomnography are discussed. Suitable patients will be informed about the trial. The investigator should provide the patient ample time and opportunity to inquire about details of the study and to decide whether or not to participate in the study. Informed Consent The participant must personally sign and date the latest approved version of the Informed Consent form. Written and verbal versions of the Participant Information and Informed Consent will be presented to the participants detailing: the exact nature of the trial; what it will involve for the participant; the implications and constraints of the protocol; the known side effects and any risks involved in taking part. It will be clearly stated that the participant is free to withdraw from the trial at any time for any reason without prejudice to future care, without affecting their legal rights and with no obligation to give the reason for withdrawal. Baseline Assessments At the baseline visit, the consultant will go through the informed consent form with the participants. Minimal clinical examination must include: Height Weight Neck collar size Friedman score for oral examination Tonsil size Palatal assessment The investigative site may wish to include other standard aspects of clinical examination records standard for their unit for example: blood pressure, endoscopy etc. Subsequent Visits Week 1 7 day recording of Visual Analog Scale (VAS) - Participant's bed partner will be required to complete daily visual analogue scoring of the participant's snoring, with 1 being "no snoring" and 10 being "intolerable snoring" Participant and bed partner to complete sleep quality and quality of life questionnaires (Pittsburgh Sleep Quality Index (PSQI), EQ-5D-5L and Epworth sleepiness score (ESS)) on Day 7 Week 2 - 7 Device handover: participant receives device and instructions on how to use The device is used once daily for six weeks Compliance is monitored centrally at Signifier Medical Technologies Ltd. Week 7 7 day recording of Visual Analogue Scale (VAS) Two night sleep study completed using watchPAT One night polysomnography Participants weight measured Participant and bed partner to complete sleep quality and quality of life questionnaires (Pittsburgh Sleep Quality Index (PSQI), EQ-5D-5L and Epworth sleepiness score (ESS)) on Day 49 3 months and 6 months Participants to complete follow up questionnaire on sleep quality and quality of life One night polysomnography repeated at 3 and 6 months. Sleep study (WatchPAT) repeated at 3 and 6 months Study Device Description The eXciteOSA transoral neurostimulation device is a home use device controlled by a mobile app. Its primary indication is for use in snoring in primary snorers or individuals with mild sleep apnoea. It is reusable device that produces muscular stimulation via electrodes integrated into a mouthpiece used by the candidate. The product will be supplied be Signifier Medical Technologies ltd. The eXciteOSA device comes in a black box which contains the control unit, mouthpiece, universal serial bus (USB) cable and the instructions for use. Only the supplied products should be used together. Use of the product should be discontinued if it appears damaged in any way. The mouthpiece is connected to the control unit via a USB port and Bluetooth connection is established between the control unit and the app. The device is to be used whilst awake, once daily for 20 minutes. The app automatically times the session and terminates it once completed. The therapy consists of a series of pulse bursts with the basic characteristic of 6 secs burst and 4 seconds rest. During the 20 mins therapy period the pulse frequency will change every 5 mins in a defined sequence. The intensity of the pulses can be controlled be the participant using the app, from a scale of 1 to 15. Patients should select the highest level they can tolerate without any discomfort.

Tracking Information