An interventional study of LP Er:YAG and SMOOTH mode Er:YAG in Snoring, sponsored by Luis Monteiro. Recruiting at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-01.
Sponsored by Luis Monteiro · Not applicable, Interventional, and Treatment
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).
122 studies on the registry are indexed under Snoring; 15 are open to participants now.
This study's planned enrollment of 75 is above the median of 43 across 95 interventional studies indexed under Snoring.
Browse Snoring studies →Luis Monteiro is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Long-pulse (LP) Er:YAG laser snoring treatment.
Device: LP Er:YAG
Fotona SMOOTH mode Er:YAG laser snoring treatment.
Device: SMOOTH mode Er:YAG
Sham laser snoring treatment with no energy applied.
Device: sham
LP Er:YAG applied to oral mucosa
Also known as: long-pulsed erbium YAG laser, LP NightLase
SMOOTH mode Er:YAG applied to oral mucosa
Also known as: SMOOTH mode erbium YAG laser, SMOOTH mode NightLase
Er:YAG laser applied to oral mucosa with no energy
Also known as: placebo
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: 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) .
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
Plan to share: No
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