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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
75
LP Er:YAG applied to oral mucosa
SMOOTH mode Er:YAG applied to oral mucosa
Er:YAG laser applied to oral mucosa with no energy
Instituto Universitário de Ciências da Saude, CESPU
Porto, Portugal
RECRUITINGNightLase 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) .
Time frame: 6 months
Change from baseline in snoring value
Snorelab software used to record snoring
Time frame: 1 month
Change from baseline in snoring value
Snorelab software used to record snoring
Time frame: 3 months
Change from baseline in snoring value
Snorelab software used to record snoring
Time frame: 12 months
Change from baseline in snoring value
Snorelab software used to record snoring
Time frame: 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) .
Time frame: 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) .
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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) .
Time frame: 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) .
Time frame: 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) .
Time frame: 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) .
Time frame: 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) .
Time frame: 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'.
Time frame: 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'.
Time frame: 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'.
Time frame: 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'.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Change in Apnea - Hypopnea Index (AHI) from baseline.
Measured by polysomnography.
Time frame: 3 months
Change in O2 saturation (%) from baseline.
Measured by polysomnography.
Time frame: 3 months
Change in snoring time (mean duration of episode in s) from baseline.
Measured by polysomnography.
Time frame: 3 months
Change in percentage snoring time of total sleep time (%) from baseline.
Measured by polysomnography.
Time frame: 3 months