An interventional study of eXciteOSA in Snoring and Sleep Apnea, Obstructive, sponsored by Signifier Medical Technologies. Status unknown at 6 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-02.
Sponsored by Signifier Medical Technologies · Not applicable, Interventional, and Treatment
It has been shown that a common cause for snoring and throat obstruction (obstructive sleep apnoea (OSA)) is excessive loss of muscle tone in the throat when the investigators go to sleep. This results in the partial collapse of the throat (snoring) or complete collapse (OSA) during sleep.
45% of the male population snore. Sleep apnoea affects 4 to 6% of the population and is associated with increased incidence of raised blood pressure, heart attacks and strokes. Although there are several lifestyle practices associated with snoring such as smoking, obesity and drinking, a significant proportion of people may snore despite not being associated with these.
A solution to this issue is to improve the muscle tone of the throat so that it doesn't collapse so easily. Several studies have shown that certain types of throat exercises can help reduce snoring. Further studies have also shown that using electrical stimulation to exercise the tongue muscles has the same effect.
From this, doctors in the United Kingdom (UK) have developed a new type of device, eXciteOSA, that allows a more accurate and comfortable way of delivering this energy to exercise the tongue muscles. The device works by stimulating the tongue muscles during the day so that the tongue is less likely to collapse during sleep. It is a form of "workout" for the tongue and like other physical exercise regimes, it needs to be repeated regularly for a few weeks to take effect.
The aim of this study is to see if the eXciteOSA device is as effective as the previous methods and if it can reduce snoring and improve sleep quality.
This will be achieved by participants using the eXciteOSA once daily for a six week period. A two night sleep study with watchPAT along with a polysomnography will be completed before and after the therapy to compare results. Questionnaires on sleep quality and quality of life will also be completed pre and post therapy.
Study Design: Phase IV prospective, multi-centre post-market surveillance study.
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.
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.
122 studies on the registry are indexed under Snoring; 15 are open to participants now.
This study's planned enrollment of 200 is above the median of 43 across 95 interventional studies indexed under Snoring.
Browse Snoring studies →Signifier Medical Technologies is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Six week use of eXciteOSA device. Once daily for 20 minutes.
Device: eXciteOSA
eXciteOSA transoral neurostimulation device
Change in sleep disordered breathing indices - Apnea Hypopnea Index (AHI)
To assess the efficacy of daytime trans-oral neuromuscular stimulation training on respiratory indices of Sleep disordered breathing (AHI)
Time frame: Change between pre-therapy (day 0) and post therapy (day 49)
Change in sleep disordered breathing indices - Oxygen Desaturation Index (ODI)
To assess the efficacy of daytime trans-oral neuromuscular stimulation training on respiratory indices of Sleep disordered breathing (ODI)
Time frame: Change between pre-therapy (day 0) and post therapy (day 49)
Change in Objective snoring pre and post therapy
To assess the efficacy of daytime trans-oral neuromuscular stimulation training on objective snoring in Sleep disordered breathing (% snoring at 40, 45 and 50dB)
Time frame: Change between pre-therapy (day 0) and post therapy (day 49)
Comparison of sleep quality questionnaires at start and end of therapy - Pittsburgh Sleep Quality Index (PSQI)
To assess the efficacy of daytime trans-oral neuromuscular stimulation training on snoring sleep quality.
Time frame: Change between pre-therapy (day 7) and post therapy (day 49)
Comparison of sleep quality questionnaires at start and end of therapy - Epsworth Sleepiness Score (ESS)
To assess the efficacy of daytime trans-oral neuromuscular stimulation training on snoring sleep quality.
Time frame: Change between pre-therapy (day 7) and post therapy (day 49)
Comparison of visual analogue scale (VAS) of snoring reported by partner
To assess the efficacy of daytime trans-oral neuromuscular stimulation training on snoring reported by sleep partner
Time frame: Change between pre-therapy (day 7) and post therapy (day 49)
Comparison of quality of life questionnaires at start and end of therapy - EQ-5D-5L
To assess the efficacy of daytime trans-oral neuromuscular stimulation training on quality of life.
Time frame: Change between pre-therapy (day 7) and post therapy (day 49)
Plan to share: No
No publications or documents are linked to this record.
Started May 2020 (actual). Primary completion is estimated for Dec 2022, 31 months after the start.
Of 45 interventional studies with no phase under Snoring, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 31. This study's planned 31 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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