SnoringNCT03829956
Intraoral Tongue Stimulation for Treatment of Primary Snoring
A study testing Intraoral tongue stimulator (Snoozeal) in people with Snoring and Obstructive Sleep Apnea, run by Signifier Medical Technologies at 1 site in United Kingdom.
Trial summary
Intraoral Neuromuscular Training for Treatment of Snoring Objective Studies show that improving pharyngeal muscle tone can ameliorate obstructive sleep apnoea (OSA) and snoring. The study uses an intra-oral stimulation device (SnooZeal) aimed at a population of snorers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Snoring, Obstructive Sleep Apnea
- What is being tested?
- Intraoral tongue stimulator (Snoozeal)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Feb 2019to 14 Apr 2020
- 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
- Age 18 years and above at entry into study
- Subjects must have a live-in partner
- > 6 months history of habitual snoring (>5 days per week)
Who cannot join
- Body Mass Index > 35
- Apnoea-Hypopnoea Index >15
- Symptomatic nasal pathology
- Tonsil Hypertrophy (Tonsil size > Grade 2)
- Tongue or lip piercing
- Pacemaker or implanted medical electrical devices
Show all 10Show fewer
- Previous oral surgery for snoring
- Relevant facial skeletal abnormalities
- Certain oral disease/conditions (see Appendix 3)
- 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
1 site in 1 country.
About this study
Official title: The Efficacy of Intra-oral Neuromuscular Stimulation Training on Primary Snoring
Intraoral Neuromuscular Training for Treatment of Snoring
Objective
Read more
Studies show that improving pharyngeal muscle tone can ameliorate obstructive sleep apnoea (OSA) and snoring. The study uses an intra-oral stimulation device (SnooZeal) aimed at a population of snorers. The aim of this study is to assess the efficacy of intra-oral neuromuscular stimulation training during wakefulness on snoring.
Methods
This is a prospective study, recruiting up to 200 patients from the sleep clinics.
In this study, subjects will use the intra-oral stimulation device once a day for 20 minutes each time for a period of 6 weeks. During these 6 weeks, subjects will complete a daily diary of the device use and any side effects or adverse events. Partners also complete a daily snoring score.
Subjects will be followed-up for a further 2 weeks after treatment. They will complete Pittsburgh Sleep Quality Index (PSQI) and subjective sleep quality questionnaires for a further 2 weeks. Partners will also complete the post treatment snoring scores. Sleep study will be repeated.
Outcome measures
The objective evaluation will be based on pre- and post-treatment sleep studies, visual analogue scale (VAS) snoring scores, PSQI and subjective sleep quality questionnaire. All side effects and adverse events will be reported and acted upon according to the risk management structure.
Read the detailed description
Aim/ Objective
The aim of this study will be to assess the efficacy of transoral neuromuscular stimulation training during wakefulness on snoring.
Patients and Methods
This is a prospective observational study, recruiting patients from the sleep clinics at the Department of Otorhinolaryngology, Head and Neck Surgery in Queen's Hospital, Barking, Havering and Redbridge University Hospitals National Health Service (NHS) Trust
Sample size planned is up to 200 participants.
Study Protocol
- Screening Participants will be identified from Queen's Hospital, Barking, Havering and Redbridge NHS Trust. There will be a screening phone call to ensure suitability based on an inclusion criterion and offer first line information about the trial. If suitable, participants will be given a written information sheet and invited to undertake a 2 day home sleep study (using WatchPAT). If the average apnea-hypopnea index (AHI) from these 2 days is below 15/h, the participants will be invited for a clinical examination.
- Recruitment visit
- Clinical airway examination by Ear, Nose and Throat (ENT) consultant
- Review of inclusion and exclusion criteria
- Informed consent
- Inclusion into trial
- Pre-therapy period (day -14 to -1):
- Bed partner daily subjective assessment of snoring (Visual Analogue Scale - 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")
- Oral examination (detailed examination by dentist to document pre-therapy oral state
- Participant and bed partner to complete sleep quality questionnaires (Pittsburgh Sleep Quality Index, Epsworth sleepiness score (ESS) and subjective sleep quality questionnaire) on Day -1
- Therapy phase (day 1-42)
- Face-to-face meeting, instruction on use of the intraoral device
- Participant to use the Snoozeal device for 20 minutes once daily
- Bed partner daily subjective assessment of snoring (VAS)
- Participant daily assessment of side effects/adverse events and time of use
- Participant and bed partner to complete Sleep quality Questionnaires (Pittsburgh Sleep Quality Index, Epsworth sleepiness score and subjective sleep quality questionnaire) at day 42
- Weekly follow up phone call from research team to confirm compliance. Compliance will also be cross checked using the total time of use recorded by the device.
- End of Therapy Review (day 43 - 49)
- Review of device integrity by visual inspection
- Oral examination (detailed examination by dentist to document post therapy oral state)
- Repeat Sleep Study - 2 night sleep study with WatchPAT
- Follow Up phase (day 43-56)
- Participant advised to stop using device
- Bed partner daily subjective assessment of snoring (VAS)
- Subject and bed partner to complete Sleep quality Questionnaires (Pittsburgh Sleep Quality Index, Epworth sleepiness score and subjective sleep quality questionnaire) at day 56
- Post Therapy Review (day 57)
- Face-to-face meeting and feedback
- Collection of participant data sheets
- Participant subjective overall assessment
Data Analysis
The pre and post sleep studies will be performed using WatchPAT. Parameters recorded: saturation, AHI, snoring sound parameters.
AHI will be identified and analyzed by WatchPAT data and software. The WatchPat is an approved FDA sleep study device. Snoring will be quantified subjectively by both the bed partner using a visual analog score, and objectively during the home sleep study as frequency of snores (number of snores / hours of sleep) and % total sleep time spent snoring. Sleep quality will be quantified subjectively by PSQI score. Sleepiness will be quantified subjectively by ESS score.
- Conditions
- Snoring, Obstructive Sleep Apnea
- Being tested
- Intraoral tongue stimulator (Snoozeal)
- Keywords
- snoring, obstructive sleep apnoea, hypopnoea
- 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.
Intraoral tongue stimulator (Snoozeal)Device
Electrical stimulation of the tongue muscle to improve muscle tone to treat primary snoring and mild obstructive sleep apnea.
| Study group | Role | What they receive |
|---|---|---|
| Snoring and mild OSA | Other | This cohort of participants has been diagnosed with primary snoring or mild obstruction sleep apnoea. A medical device (intra-oral tongue stimulation device) will be introduced for 6 weeks and the effects will be assessed by comparing the outcome measures before and after the intervention. Receives: Device: Intraoral tongue stimulator (Snoozeal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in snoring levels greater than 40dB
Reduction of 20 % in the percentage of time spent snoring at levels greater than 40 dB. This will be achieved using WatchPat (510K - K161579) sleep studies
Measured: Change between pre-therapy (day -14 to -1) and end of therapy (day 43-49)
Visual analogue scale (VAS) snoring scores
Visual analogue scale (VAS) of snoring is a subjective assessment of the participant's severity of scoring by their partner on a scale of 1 - 10 (1 being no snoring, 10 being intolerable snoring). This assessment will be done on a daily basis for the 2 weeks prior to intervention, 6 weeks of intervention and 2 weeks post intervention.
Measured: Change between average of pre-therapy (day -14 to day -1), during therapy (day 29 to 42) and post therapy (day 43 to 56)
Secondary outcomes (2)
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index is a self-report questionnaire that is completed by the participants at day -1 (pre-therapy), day 42 (end of therapy) and day 56 (post therapy). The questions are multiple choice questions with the answers based on participants' usual sleep habits during the last four weeks. The outcome is assessed based on the evaluation of the change in responses before and after therapy. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: Change between pre-therapy (day -1) and post therapy (day 56)
Epworth Sleepiness Scale (ESS)
The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The score can range from 0 to 24, with a higher score indicating a higher level of daytime sleepiness.
Measured: Change between pre-therapy (day -1) and post therapy (day 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start4 Feb 2019
- Primary completion14 Apr 2020
- Study completion14 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Signifier Medical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bhik Kotecha, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829956
- Sponsor's protocol ID
- Snoozeal
- Status last verified
- Sep 2021
- First submitted
- 13 Jan 2017
- Last updated
- 27 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nokes B, Baptista PM, de Apodaca PMR, Carrasco-Llatas M, Fernandez S, Kotecha B, Wong PY, Zhang H, Hassaan A, Malhotra A. Transoral awake state neuromuscular electrical stimulation therapy for mild obstructive sleep apnea. Sleep Breath. 2023 May;27(2):527-534. doi: 10.1007/s11325-022-02644-9. Epub 2022 May 27.
PubMed 35624401Kotecha B, Wong PY, Zhang H, Hassaan A. A novel intraoral neuromuscular stimulation device for treating sleep-disordered breathing. Sleep Breath. 2021 Dec;25(4):2083-2090. doi: 10.1007/s11325-021-02355-7. Epub 2021 Mar 26.
PubMed 33772397
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Intra-oral Neuromuscular Stimulation Training on Primary Snoring
- ClinicalTrials.gov ID
- NCT03829956
- Acronym / sponsor ID
- Snoozeal
- Conditions
- Snoring, Obstructive Sleep Apnea
- Keywords
- snoring, obstructive sleep apnoea, hypopnoea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Signifier Medical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 14 Apr 2020 (actual)
- Study completion
- 14 Apr 2020 (actual)
- First posted
- 4 Feb 2019 (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.
Intraoral Neuromuscular Training for Treatment of Snoring
Objective
Studies show that improving pharyngeal muscle tone can ameliorate obstructive sleep apnoea (OSA) and snoring. The study uses an intra-oral stimulation device (SnooZeal) aimed at a population of snorers. The aim of this study is to assess the efficacy of intra-oral neuromuscular stimulation training during wakefulness on snoring.
Methods
This is a prospective study, recruiting up to 200 patients from the sleep clinics.
In this study, subjects will use the intra-oral stimulation device once a day for 20 minutes each time for a period of 6 weeks. During these 6 weeks, subjects will complete a daily diary of the device use and any side effects or adverse events. Partners also complete a daily snoring score.
Subjects will be followed-up for a further 2 weeks after treatment. They will complete Pittsburgh Sleep Quality Index (PSQI) and subjective sleep quality questionnaires for a further 2 weeks. Partners will also complete the post treatment snoring scores. Sleep study will be repeated.
Outcome measures
The objective evaluation will be based on pre- and post-treatment sleep studies, visual analogue scale (VAS) snoring scores, PSQI and subjective sleep quality questionnaire. All side effects and adverse events will be reported and acted upon according to the risk management structure.
Detailed description
Aim/ Objective
The aim of this study will be to assess the efficacy of transoral neuromuscular stimulation training during wakefulness on snoring.
Patients and Methods
This is a prospective observational study, recruiting patients from the sleep clinics at the Department of Otorhinolaryngology, Head and Neck Surgery in Queen's Hospital, Barking, Havering and Redbridge University Hospitals National Health Service (NHS) Trust
Sample size planned is up to 200 participants.
Study Protocol
- Screening Participants will be identified from Queen's Hospital, Barking, Havering and Redbridge NHS Trust. There will be a screening phone call to ensure suitability based on an inclusion criterion and offer first line information about the trial. If suitable, participants will be given a written information sheet and invited to undertake a 2 day home sleep study (using WatchPAT). If the average apnea-hypopnea index (AHI) from these 2 days is below 15/h, the participants will be invited for a clinical examination.
- Recruitment visit
- Clinical airway examination by Ear, Nose and Throat (ENT) consultant
- Review of inclusion and exclusion criteria
- Informed consent
- Inclusion into trial
- Pre-therapy period (day -14 to -1):
- Bed partner daily subjective assessment of snoring (Visual Analogue Scale - 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")
- Oral examination (detailed examination by dentist to document pre-therapy oral state
- Participant and bed partner to complete sleep quality questionnaires (Pittsburgh Sleep Quality Index, Epsworth sleepiness score (ESS) and subjective sleep quality questionnaire) on Day -1
- Therapy phase (day 1-42)
- Face-to-face meeting, instruction on use of the intraoral device
- Participant to use the Snoozeal device for 20 minutes once daily
- Bed partner daily subjective assessment of snoring (VAS)
- Participant daily assessment of side effects/adverse events and time of use
- Participant and bed partner to complete Sleep quality Questionnaires (Pittsburgh Sleep Quality Index, Epsworth sleepiness score and subjective sleep quality questionnaire) at day 42
- Weekly follow up phone call from research team to confirm compliance. Compliance will also be cross checked using the total time of use recorded by the device.
- End of Therapy Review (day 43 - 49)
- Review of device integrity by visual inspection
- Oral examination (detailed examination by dentist to document post therapy oral state)
- Repeat Sleep Study - 2 night sleep study with WatchPAT
- Follow Up phase (day 43-56)
- Participant advised to stop using device
- Bed partner daily subjective assessment of snoring (VAS)
- Subject and bed partner to complete Sleep quality Questionnaires (Pittsburgh Sleep Quality Index, Epworth sleepiness score and subjective sleep quality questionnaire) at day 56
- Post Therapy Review (day 57)
- Face-to-face meeting and feedback
- Collection of participant data sheets
- Participant subjective overall assessment
Data Analysis
The pre and post sleep studies will be performed using WatchPAT. Parameters recorded: saturation, AHI, snoring sound parameters.
AHI will be identified and analyzed by WatchPAT data and software. The WatchPat is an approved FDA sleep study device. Snoring will be quantified subjectively by both the bed partner using a visual analog score, and objectively during the home sleep study as frequency of snores (number of snores / hours of sleep) and % total sleep time spent snoring. Sleep quality will be quantified subjectively by PSQI score. Sleepiness will be quantified subjectively by ESS score.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Snoring and mild OSA | Other | Device: Intraoral tongue stimulator (Snoozeal)This cohort of participants has been diagnosed with primary snoring or mild obstruction sleep apnoea. A medical device (intra-oral tongue stimulation device) will be introduced for 6 weeks and the effects will be assessed by comparing the outcome measures before and after the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years and above at entry into study
- Subjects must have a live-in partner
- > 6 months history of habitual snoring (>5 days per week)
Key exclusion criteria (10 listed)
- Body Mass Index > 35
- Apnoea-Hypopnoea Index >15
- Symptomatic nasal pathology
- Tonsil Hypertrophy (Tonsil size > Grade 2)
- 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 |
|---|---|---|
| Intraoral tongue stimulator (Snoozeal)Electrical stimulation of the tongue muscle to improve muscle tone to treat primary snoring and mild obstructive sleep apnea. | Device | Snoring and mild OSA |
Primary outcome
Reduction in snoring levels greater than 40dB
Time frame: Change between pre-therapy (day -14 to -1) and end of therapy (day 43-49)
Reduction of 20 % in the percentage of time spent snoring at levels greater than 40 dB. This will be achieved using WatchPat (510K - K161579) sleep studies
Visual analogue scale (VAS) snoring scores
Time frame: Change between average of pre-therapy (day -14 to day -1), during therapy (day 29 to 42) and post therapy (day 43 to 56)
Visual analogue scale (VAS) of snoring is a subjective assessment of the participant's severity of scoring by their partner on a scale of 1 - 10 (1 being no snoring, 10 being intolerable snoring). This assessment will be done on a daily basis for the 2 weeks prior to intervention, 6 weeks of intervention and 2 weeks post intervention.
2 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change between pre-therapy (day -1) and post therapy (day 56)
Epworth Sleepiness Scale (ESS)
Time frame: Change between pre-therapy (day -1) and post therapy (day 56)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Derived from this study: PubMed 35624401Nokes B, Baptista PM, de Apodaca PMR, Carrasco-Llatas M, Fernandez S, Kotecha B, Wong PY, Zhang H, Hassaan A, Malhotra A. Transoral awake state neuromuscular electrical stimulation therapy for mild obstructive sleep apnea. Sleep Breath. 2023 May;27(2):527-534. doi: 10.1007/s11325-022-02644-9. Epub 2022 May 27.
- Derived from this study: PubMed 33772397Kotecha B, Wong PY, Zhang H, Hassaan A. A novel intraoral neuromuscular stimulation device for treating sleep-disordered breathing. Sleep Breath. 2021 Dec;25(4):2083-2090. doi: 10.1007/s11325-021-02355-7. Epub 2021 Mar 26.
- 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.
Bhik Kotecha principal investigator
University College London Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoral tongue stimulator (Snoozeal) in people with Snoring and Obstructive Sleep Apnea, run by Signifier Medical Technologies at 1 site in United Kingdom.
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 3 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: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in snoring levels greater than 40dB (time frame: Change between pre-therapy (day -14 to -1) and end of therapy (day 43-49)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03829956, which also lists 2 linked publications.
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 27 Sep 2021.