SnoringNCT04392765
Efficacy of Intra-oral Neuromuscular Stimulation Training on Snoring and Mild Sleep Apnoea
A study testing eXciteOSA in people with Snoring and Sleep Apnea, Obstructive, run by Signifier Medical Technologies at 6 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Snoring, Sleep Apnea, Obstructive
- What is being tested?
- eXciteOSA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 11 May 2020to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the trial
- Male or female, aged 18 years or above
- AHI 5-15/hr as confirmed by polysomnography performed for screening purposes
- Snoring complaints for >6 months
- In possession of a smartphone (to use the application)
Who cannot join
- BMI >35 kg/m2
- AHI >15/h, i.e. evidence of moderate to severe obstructive sleep apnoea (OSA) from polysomnography
- Symptomatic nasal pathology i.e. septal deviation, nasal polyposis or chronic rhinosinusitis
- Tonsil Hypertrophy (Tonsil size - Grade 3 or greater)
- Tongue or lip piercing
- Pacemaker or implanted medical electrical devices
Show all 10Show fewer
- Previous oral surgery for snoring
- Relevant facial skeletal abnormalities (i.e. syndromic facial deficiencies, severe micrognathia etc.)
- Pregnancy or planned pregnancy
- Any criteria that, in the opinion of the investigator, would make the participant unsuitable for the study due to inability to complete required study procedures
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Canada2 sites
McGill University Health Centre
Montreal
Vancouver Hospital
Vancouver, British Columbia, V5Z 1M9
Spain2 sites
Clínica Universidad de Navarra, Pamplona
Pamplona
Hospital Universitario Doctor Peset, Valencia
Valencia
About this study
Official title: The Efficacy of Intra-oral Neuromuscular Stimulation Training on Snoring in Individuals With Primary Snoring or Mild Sleep Apnoea - A Multi Centre Trial
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Snoring, Sleep Apnea, Obstructive
- Being tested
- eXciteOSA
- Medical subject headings
- Snoring, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eXciteOSADevice
eXciteOSA transoral neurostimulation device
| Study group | Role | What they receive |
|---|---|---|
| Therapy arm | Other | Six week use of eXciteOSA device. Once daily for 20 minutes. Receives: Device: eXciteOSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: Change between pre-therapy (day 0) and post therapy (day 49)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Change between pre-therapy (day 7) and post therapy (day 49)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start11 May 2020
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SnoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Signifier Medical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yasser Zayni, Study director, Signifier Medical Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392765
- Sponsor's protocol ID
- eXciteOSA Multicentre
- Status last verified
- Dec 2022
- First submitted
- 11 May 2020
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Intra-oral Neuromuscular Stimulation Training on Snoring in Individuals With Primary Snoring or Mild Sleep Apnoea - A Multi Centre Trial
- ClinicalTrials.gov ID
- NCT04392765
- Acronym / sponsor ID
- eXciteOSA Multicentre
- Conditions
- Snoring, Sleep Apnea, Obstructive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Signifier Medical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 11 May 2020 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapy arm | Other | Device: eXciteOSASix week use of eXciteOSA device. Once daily for 20 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant is willing and able to give informed consent for participation in the trial
- Male or female, aged 18 years or above
- AHI 5-15/hr as confirmed by polysomnography performed for screening purposes
- Snoring complaints for >6 months
- In possession of a smartphone (to use the application)
Key exclusion criteria (10 listed)
- BMI >35 kg/m2
- AHI >15/h, i.e. evidence of moderate to severe obstructive sleep apnoea (OSA) from polysomnography
- Symptomatic nasal pathology i.e. septal deviation, nasal polyposis or chronic rhinosinusitis
- Tonsil Hypertrophy (Tonsil size - Grade 3 or greater)
- Tongue or lip piercing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eXciteOSAeXciteOSA transoral neurostimulation device | Device | Therapy arm |
Primary outcome
Change in sleep disordered breathing indices - Apnea Hypopnea Index (AHI)
Time frame: Change between pre-therapy (day 0) and post therapy (day 49)
To assess the efficacy of daytime trans-oral neuromuscular stimulation training on respiratory indices of Sleep disordered breathing (AHI)
Change in sleep disordered breathing indices - Oxygen Desaturation Index (ODI)
Time frame: Change between pre-therapy (day 0) and post therapy (day 49)
To assess the efficacy of daytime trans-oral neuromuscular stimulation training on respiratory indices of Sleep disordered breathing (ODI)
Change in Objective snoring pre and post therapy
Time frame: Change between pre-therapy (day 0) and post therapy (day 49)
To assess the efficacy of daytime trans-oral neuromuscular stimulation training on objective snoring in Sleep disordered breathing (% snoring at 40, 45 and 50dB)
4 secondary outcomes
Comparison of sleep quality questionnaires at start and end of therapy - Pittsburgh Sleep Quality Index (PSQI)
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)
Time frame: Change between pre-therapy (day 7) and post therapy (day 49)
Comparison of visual analogue scale (VAS) of snoring reported by 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
Time frame: Change between pre-therapy (day 7) and post therapy (day 49)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasser Zayni study director
Signifier Medical Technologies
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eXciteOSA in people with Snoring and Sleep Apnea, Obstructive, run by Signifier Medical Technologies at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada, Spain, Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep disordered breathing indices - Apnea Hypopnea Index (AHI) (time frame: Change between pre-therapy (day 0) and post therapy (day 49)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.