Clinical Tial of Er:YAG Laser Snoring Treatment
- Conditions
- Snoring
- Interventions
- Device: sham
- Registration Number
- NCT03947424
- Lead Sponsor
- Luis Monteiro
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
- 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
- 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%).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control sham Sham laser snoring treatment with no energy applied.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change from baseline in snoring value 6 months Snorelab software used to record snoring
NightLase Snoring Questionnaire-Question 1: Snoring severity 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 Quality of life Questionnaire score from baseline 12 months 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 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.
NightLase Snoring Questionnaire change from baseline 12 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) .
Change in EpWorth somnolence scale from baseline 12 months 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 Apnea - Hypopnea Index (AHI) from baseline. 3 months Measured by polysomnography.
Change in O2 saturation (%) from baseline. 3 months Measured by polysomnography.
Trial Locations
- Locations (1)
Instituto Universitário de Ciências da Saude, CESPU
🇵🇹Porto, Portugal