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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.
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
A. 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.
B. Recruitment visit
C. Pre-therapy period (day -14 to -1):
D. Therapy phase (day 1-42)
E. End of Therapy Review (day 43 - 49)
F. Follow Up phase (day 43-56)
G. Post Therapy Review (day 57)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoral tongue stimulator (Snoozeal) | Device | Electrical stimulation of the tongue muscle to improve muscle tone to treat primary snoring and mild obstructive sleep apnea. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Change between average of pre-therapy (day -14 to day -1), during therapy (day 29 to 42) and post therapy (day 43 to 56) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bhik Kotecha | University College London Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Redbridge, Barking and Havering NHS Trust | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35624401 | Derived | 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. | |
| 33772397 | Derived |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 27, 2018 | Jan 28, 2019 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 27, 2018 | Jan 28, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012913 | Snoring |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. | Change between pre-therapy (day -1) and post therapy (day 56) |
| Kotecha 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. |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |