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Two modes of laser (Er:YAG) treatment for snoring will be compared with sham treatment in a randomized clinical trial.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1 | Experimental | Long-pulse (LP) Er:YAG laser snoring treatment. |
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| Experimental 2 | Experimental | Fotona SMOOTH mode Er:YAG laser snoring treatment. |
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| Control | Sham Comparator | Sham laser snoring treatment with no energy applied. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LP Er:YAG | Device | LP Er:YAG applied to oral mucosa |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luis Monteiro, DMD, PhD | Contact | +351 919120226 | luis.monteiro@iucs.cespu.pt |
| Name | Affiliation | Role |
|---|---|---|
| Luis Monteiro, DMD, PhD | Instituto Universitário de Ciências da Saude, CESPU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Universitário de Ciências da Saude, CESPU | Recruiting | Porto | 4585-116 | Portugal |
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| ID | Term |
|---|---|
| D012913 | Snoring |
| ID | Term |
|---|---|
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Three groups; laser (LP), laser (SMOOTH), control (sham)
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Sham treatment consists of laser treatment according to the same protocol as active treatment but with no energy applied. Clinical measurements will be performed by an evaluator unaware of group assignment.
| SMOOTH mode Er:YAG | Device | SMOOTH mode Er:YAG applied to oral mucosa |
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| sham | Device | Er:YAG laser applied to oral mucosa with no energy |
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| 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 |