Intraoral Tongue Stimulation for Treatment of Primary Snoring
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| ClinicalTrials.gov Identifier: NCT03829956 |
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Recruitment Status :
Completed
First Posted : February 4, 2019
Last Update Posted : September 27, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Snoring Obstructive Sleep Apnea | Device: Intraoral tongue stimulator (Snoozeal) | Not Applicable |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 115 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | The Efficacy of Intra-oral Neuromuscular Stimulation Training on Primary Snoring |
| Actual Study Start Date : | February 4, 2019 |
| Actual Primary Completion Date : | April 14, 2020 |
| Actual Study Completion Date : | April 14, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Snoring and mild OSA
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.
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Device: Intraoral tongue stimulator (Snoozeal)
Electrical stimulation of the tongue muscle to improve muscle tone to treat primary snoring and mild obstructive sleep apnea. |
- 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.
- Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Change between pre-therapy (day -1) and post therapy (day 56) ]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.
- Epworth Sleepiness Scale (ESS) [ Time Frame: Change between pre-therapy (day -1) and post therapy (day 56) ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829956
| United Kingdom | |
| Redbridge, Barking and Havering NHS Trust | |
| London, United Kingdom | |
| Principal Investigator: | Bhik Kotecha | University College London Hospitals |
Documents provided by Signifier Medical Technologies:
| Responsible Party: | Signifier Medical Technologies |
| ClinicalTrials.gov Identifier: | NCT03829956 |
| Other Study ID Numbers: |
Snoozeal |
| First Posted: | February 4, 2019 Key Record Dates |
| Last Update Posted: | September 27, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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snoring obstructive sleep apnoea hypopnoea |
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Sleep Apnea Syndromes Sleep Apnea, Obstructive Snoring Apnea Respiration Disorders Respiratory Tract Diseases |
Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Respiratory Sounds Signs and Symptoms, Respiratory |