Clinical Tial of Er:YAG Laser Snoring Treatment

Snoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03947424
• Other study ID #: 16/CE-IUCS/2018
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: May 1, 2024

Study information

• Verified date: August 2023
• Source: Cooperativa de Ensino Superior, Politécnico e Universitário
• Contact: Luis Monteiro, DMD, PhD
• Phone: +351 919120226
• Email: luis.monteiro[@]iucs.cespu.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: May 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%).

Related Conditions & MeSH terms

• Snoring

Intervention

Device:
• LP Er:YAG
LP Er:YAG applied to oral mucosa
• SMOOTH mode Er:YAG
SMOOTH mode Er:YAG applied to oral mucosa
• sham
Er:YAG laser applied to oral mucosa with no energy

Locations

Country	Name	City	State
Portugal	Instituto Universitário de Ciências da Saude, CESPU	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Luis Monteiro

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline in snoring value	Snorelab software used to record snoring	1 month
Secondary	Change from baseline in snoring value	Snorelab software used to record snoring	3 months
Secondary	Change from baseline in snoring value	Snorelab software used to record snoring	12 months
Secondary	Change from baseline in snoring value	Snorelab software used to record snoring	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Apnea - Hypopnea Index (AHI) from baseline.	Measured by polysomnography.	3 months
Secondary	Change in O2 saturation (%) from baseline.	Measured by polysomnography.	3 months
Secondary	Change in snoring time (mean duration of episode in s) from baseline.	Measured by polysomnography.	3 months
Secondary	Change in percentage snoring time of total sleep time (%) from baseline.	Measured by polysomnography.	3 months