Clinical Tial of Er:YAG Laser Snoring Treatment

Study Overview
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Brief Summary
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Two modes of laser (Er:YAG) treatment for snoring will be compared with sham treatment in a randomized clinical trial.

Detailed Description
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The aim of this study is to evaluate the clinical outcome of snoring treatment using non-ablative Er:YAG laser in comparison with sham laser treatment. Furthermore, to different modes of Er:YAG laser will be compared; a long-pulse mode (LP) and proprietary SMOOTH mode (Fotona, Slovenia).

Official Title
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Safety and Efficacy of Different Modes of Er:YAG Laser Treatment for Snoring in Comparison With Placebo

Conditions
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Snoring

Intervention / Treatment
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* Device: LP Er:YAG
* Device: SMOOTH mode Er:YAG
* Device: sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed consent form Diagnosis of snoring/apnea including partner information Age greater than 18 years. Apnea-Hypopnea index (AHI) less than 30. No significant nasal stenosis. Bed partner present Exclusion Criteria: People who refuse to participate in the study Presence of concomitant disorders and/or diseases Infections in the throat current use of photosensitive drugs pregnancy scarring in the throat acute pollen allergies epilepsy People starting with an extreme diet or weight loss plan Patients who do not want to follow post treatment recommendation concerning food and drinks intake Larynx obstruction (floppy epiglottis) Oropharynx obstruction caused by palatine tonsils (>50%).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three groups; laser (LP), laser (SMOOTH), control (sham)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental 1<br>Long-pulse (LP) Er:YAG laser snoring treatment. | Device: LP Er:YAG<br>* LP Er:YAG applied to oral mucosa<br>* Other names: LP NightLase;|
| Experimental: Experimental 2<br>Fotona SMOOTH mode Er:YAG laser snoring treatment. | Device: SMOOTH mode Er:YAG<br>* SMOOTH mode Er:YAG applied to oral mucosa<br>* Other names: SMOOTH mode NightLase;|
| Sham Comparator: Control<br>Sham laser snoring treatment with no energy applied. | Device: sham<br>* Er:YAG laser applied to oral mucosa with no energy<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NightLase Snoring Questionnaire-Question 1: Snoring severity change from baseline | This questionnaire consists of eight questions, assessing the severity of snoring (the first question) and other problems associated with sleep-disordered breathing (questions 2-8). Answers will be graded on 11-point scales (0-10) . | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in snoring value | Snorelab software used to record snoring | 1 month | 
| Change from baseline in snoring value | Snorelab software used to record snoring | 3 months | 
| Change from baseline in snoring value | Snorelab software used to record snoring | 12 months | 
| Change from baseline in snoring value | Snorelab software used to record snoring | 6 months | 
| NightLase Snoring Questionnaire-Question 1: Snoring severity change from baseline | This questionnaire consists of eight questions, assessing the severity of snoring (the first question) and other problems associated with sleep-disordered breathing (questions 2-8). Answers will be graded on 11-point scales (0-10) . | 3 months | 
| NightLase Snoring Questionnaire-Question 1: Snoring severity change from baseline | This questionnaire consists of eight questions, assessing the severity of snoring (the first question) and other problems associated with sleep-disordered breathing (questions 2-8). Answers will be graded on 11-point scales (0-10) . | 12 months | 
| NightLase Snoring Questionnaire-Question 1: Snoring severity change from baseline | This questionnaire consists of eight questions, assessing the severity of snoring (the first question) and other problems associated with sleep-disordered breathing (questions 2-8). Answers will be graded on 11-point scales (0-10) . | 1 month | 
| NightLase Snoring Questionnaire change from baseline | This questionnaire consists of eight questions, assessing the severity of snoring (the first question) and other problems associated with sleep-disordered breathing (questions 2-8). Answers will be graded on 11-point scales (0-10) . | 1 month | 
| NightLase Snoring Questionnaire change from baseline | This questionnaire consists of eight questions, assessing the severity of snoring (the first question) and other problems associated with sleep-disordered breathing (questions 2-8). Answers will be graded on 11-point scales (0-10) . | 3 months | 
| NightLase Snoring Questionnaire change from baseline | This questionnaire consists of eight questions, assessing the severity of snoring (the first question) and other problems associated with sleep-disordered breathing (questions 2-8). Answers will be graded on 11-point scales (0-10) . | 6 months | 
| NightLase Snoring Questionnaire change from baseline | This questionnaire consists of eight questions, assessing the severity of snoring (the first question) and other problems associated with sleep-disordered breathing (questions 2-8). Answers will be graded on 11-point scales (0-10) . | 12 months | 
| Change in EpWorth somnolence scale from baseline | The level of daytime sleepiness in the patients was assessed using the 24-point Epworth scale. Values 0-10 are considered normal, and values 11-24 represent increasing levels of 'excessive daytime sleepiness'. | 1 month | 
| Change in EpWorth somnolence scale from baseline | The level of daytime sleepiness in the patients was assessed using the 24-point Epworth scale. Values 0-10 are considered normal, and values 11-24 represent increasing levels of 'excessive daytime sleepiness'. | 3 months | 
| Change in EpWorth somnolence scale from baseline | The level of daytime sleepiness in the patients was assessed using the 24-point Epworth scale. Values 0-10 are considered normal, and values 11-24 represent increasing levels of 'excessive daytime sleepiness'. | 6 months | 
| Change in EpWorth somnolence scale from baseline | The level of daytime sleepiness in the patients was assessed using the 24-point Epworth scale. Values 0-10 are considered normal, and values 11-24 represent increasing levels of 'excessive daytime sleepiness'. | 12 months | 
| Change in Quality of life Questionnaire score from baseline | Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life. | 1 month | 
| Change in Quality of life Questionnaire score from baseline | Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life. | 3 months | 
| Change in Quality of life Questionnaire score from baseline | Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life. | 6 months | 
| Change in Quality of life Questionnaire score from baseline | Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life. | 12 months | 
| Change in Apnea - Hypopnea Index (AHI) from baseline. | Measured by polysomnography. | 3 months | 
| Change in O2 saturation (%) from baseline. | Measured by polysomnography. | 3 months | 
| Change in snoring time (mean duration of episode in s) from baseline. | Measured by polysomnography. | 3 months | 
| Change in percentage snoring time of total sleep time (%) from baseline. | Measured by polysomnography. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laser, Er:YAG, NightLase, Fotona SMOOTH