Clinical Tial of Er:YAG Laser Snoring Treatment

Safety and Efficacy of Different Modes of Er:YAG Laser Treatment for Snoring in Comparison With Placebo

Two modes of laser (Er:YAG) treatment for snoring will be compared with sham treatment in a randomized clinical trial.

Study Overview

• Status: Recruiting
• Conditions: Snoring
• Intervention / Treatment: Device: LP Er:YAG; Device: SMOOTH mode Er:YAG; Device: sham

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).

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luis Monteiro, DMD, PhD; Phone Number: +351 919120226; Email: luis.monteiro@iucs.cespu.pt

Study Locations

• Portugal
  • Porto, Portugal, 4585-116
    • Recruiting
    • Instituto Universitário de Ciências da Saude, CESPU
    • Contact: Luis Monteiro; Phone Number: +351 919120226; Email: luis.monteiro@iucs.cespu.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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%).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental 1; Long-pulse (LP) Er:YAG laser snoring treatment.	Device: LP Er:YAG; LP Er:YAG applied to oral mucosa; Other Names: long-pulsed erbium YAG laser; LP NightLase
Experimental: Experimental 2; Fotona SMOOTH mode Er:YAG laser snoring treatment.	Device: SMOOTH mode Er:YAG; SMOOTH mode Er:YAG applied to oral mucosa; Other Names: SMOOTH mode erbium YAG laser; SMOOTH mode NightLase
Sham Comparator: Control; Sham laser snoring treatment with no energy applied.	Device: sham; Er:YAG laser applied to oral mucosa with no energy; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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) .	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in snoring value	Snorelab software used to record snoring	1 month
Change from baseline in snoring value	Snorelab software used to record snoring	3 months
Change from baseline in snoring value	Snorelab software used to record snoring	12 months
Change from baseline in snoring value	Snorelab software used to record snoring	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) .	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) .	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) .	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) .	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) .	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) .	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) .	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'.	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'.	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'.	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'.	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.	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.	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.	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.	12 months
Change in Apnea - Hypopnea Index (AHI) from baseline.	Measured by polysomnography.	3 months
Change in O2 saturation (%) from baseline.	Measured by polysomnography.	3 months
Change in snoring time (mean duration of episode in s) from baseline.	Measured by polysomnography.	3 months
Change in percentage snoring time of total sleep time (%) from baseline.	Measured by polysomnography.	3 months

Collaborators and Investigators

• Sponsor: Luis Monteiro
• Investigators: Principal Investigator: Luis Monteiro, DMD, PhD, Instituto Universitário de Ciências da Saude, CESPU

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: laser; Er:YAG; NightLase; Fotona SMOOTH
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds; Snoring
• Other Study ID Numbers: 16/CE-IUCS/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No