Snoring
Conditions
Keywords
laser, Er:YAG, NightLase, Fotona SMOOTH
Brief summary
Two modes of laser (Er:YAG) treatment for snoring will be compared with sham treatment in a randomized clinical trial.
Detailed description
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).
Interventions
DEVICELP Er:YAG
LP Er:YAG applied to oral mucosa
DEVICESMOOTH mode Er:YAG
SMOOTH mode Er:YAG applied to oral mucosa
DEVICEsham
Er:YAG laser applied to oral mucosa with no energy
Sponsors
Luis Monteiro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
Three groups; laser (LP), laser (SMOOTH), control (sham)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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%).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NightLase Snoring Questionnaire-Question 1: Snoring severity change from baseline | 6 months | 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) . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NightLase Snoring Questionnaire-Question 1: Snoring severity change from baseline | 3 months | 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) . |
| NightLase Snoring Questionnaire change from baseline | 1 month | 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) . |
| Change in EpWorth somnolence scale from baseline | 1 month | 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'. |
| Change in Quality of life Questionnaire score from baseline | 1 month | Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life. |
| Change from baseline in snoring value | 1 month | Snorelab software used to record snoring |
| Change in O2 saturation (%) from baseline. | 3 months | Measured by polysomnography. |
| Change in snoring time (mean duration of episode in s) from baseline. | 3 months | Measured by polysomnography. |
| Change in percentage snoring time of total sleep time (%) from baseline. | 3 months | Measured by polysomnography. |
| Change in Apnea - Hypopnea Index (AHI) from baseline. | 3 months | Measured by polysomnography. |
Countries
Portugal
Contacts
Primary ContactLuis Monteiro, DMD, PhD
Outcome results
None listed