Clinical trial NCT03947424: Clinical Tial of Er:YAG Laser Snoring Treatment
Official title: Safety and Efficacy of Different Modes of Er:YAG Laser Treatment for Snoring in Comparison With Placebo
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Snoring
Keywords: laser
Er:YAG
NightLase
Fotona SMOOTH
Lead sponsor: Cooperativa de Ensino Superior, Politécnico e Universitário
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups; laser (LP), laser (SMOOTH), control (sham)
Primary purpose: TREATMENT

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).

Eligibility criteria: 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%).

Primary outcomes:
measure: NightLase Snoring Questionnaire-Question 1: Snoring severity change from baseline
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline in snoring value
timeFrame: 1 month
measure: Change from baseline in snoring value
timeFrame: 3 months
measure: Change from baseline in snoring value
timeFrame: 12 months
measure: Change from baseline in snoring value
timeFrame: 6 months
measure: NightLase Snoring Questionnaire-Question 1: Snoring severity change from baseline
timeFrame: 3 months
measure: NightLase Snoring Questionnaire-Question 1: Snoring severity change from baseline
timeFrame: 12 months
measure: NightLase Snoring Questionnaire-Question 1: Snoring severity change from baseline
timeFrame: 1 month
measure: NightLase Snoring Questionnaire change from baseline
timeFrame: 1 month
measure: NightLase Snoring Questionnaire change from baseline
timeFrame: 3 months
measure: NightLase Snoring Questionnaire change from baseline
timeFrame: 6 months
measure: NightLase Snoring Questionnaire change from baseline
timeFrame: 12 months
measure: Change in EpWorth somnolence scale from baseline
timeFrame: 1 month
measure: Change in EpWorth somnolence scale from baseline
timeFrame: 3 months
measure: Change in EpWorth somnolence scale from baseline
timeFrame: 6 months
measure: Change in EpWorth somnolence scale from baseline
timeFrame: 12 months
measure: Change in Quality of life Questionnaire score from baseline
timeFrame: 1 month
measure: Change in Quality of life Questionnaire score from baseline
timeFrame: 3 months
measure: Change in Quality of life Questionnaire score from baseline
timeFrame: 6 months
measure: Change in Quality of life Questionnaire score from baseline
timeFrame: 12 months
measure: Change in Apnea - Hypopnea Index (AHI) from baseline.
timeFrame: 3 months
measure: Change in O2 saturation (%) from baseline.
timeFrame: 3 months
measure: Change in snoring time (mean duration of episode in s) from baseline.
timeFrame: 3 months
measure: Change in percentage snoring time of total sleep time (%) from baseline.
timeFrame: 3 months
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Instituto Universitário de Ciências da Saude, CESPU
Study officials:
affiliation: Instituto Universitário de Ciências da Saude, CESPU
name: Luis Monteiro, DMD, PhD
role: PRINCIPAL_INVESTIGATOR
References: