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Clinical Tial of Er:YAG Laser Snoring Treatment

Primary Purpose

Snoring

Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
LP Er:YAG
SMOOTH mode Er:YAG
sham
Sponsored by
Luis Monteiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Snoring focused on measuring laser, Er:YAG, NightLase, Fotona SMOOTH

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%).

Sites / Locations

  • Instituto Universitário de Ciências da Saude, CESPURecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Experimental 1

Experimental 2

Control

Arm Description

Long-pulse (LP) Er:YAG laser snoring treatment.

Fotona SMOOTH mode Er:YAG laser snoring treatment.

Sham laser snoring treatment with no energy applied.

Outcomes

Primary Outcome Measures

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) .

Secondary Outcome Measures

Change from baseline in snoring value
Snorelab software used to record snoring
Change from baseline in snoring value
Snorelab software used to record snoring
Change from baseline in snoring value
Snorelab software used to record snoring
Change from baseline in snoring value
Snorelab software used to record snoring
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) .
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) .
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) .
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) .
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) .
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) .
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) .
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'.
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'.
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'.
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'.
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.
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.
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.
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.
Change in Apnea - Hypopnea Index (AHI) from baseline.
Measured by polysomnography.
Change in O2 saturation (%) from baseline.
Measured by polysomnography.
Change in snoring time (mean duration of episode in s) from baseline.
Measured by polysomnography.
Change in percentage snoring time of total sleep time (%) from baseline.
Measured by polysomnography.

Full Information

First Posted
May 9, 2019
Last Updated
August 31, 2023
Sponsor
Luis Monteiro
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1. Study Identification

Unique Protocol Identification Number
NCT03947424
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Luis Monteiro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring
Keywords
laser, Er:YAG, NightLase, Fotona SMOOTH

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three groups; laser (LP), laser (SMOOTH), control (sham)
Masking
ParticipantOutcomes Assessor
Masking Description
Sham treatment consists of laser treatment according to the same protocol as active treatment but with no energy applied. Clinical measurements will be performed by an evaluator unaware of group assignment.
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental 1
Arm Type
Experimental
Arm Description
Long-pulse (LP) Er:YAG laser snoring treatment.
Arm Title
Experimental 2
Arm Type
Experimental
Arm Description
Fotona SMOOTH mode Er:YAG laser snoring treatment.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Sham laser snoring treatment with no energy applied.
Intervention Type
Device
Intervention Name(s)
LP Er:YAG
Other Intervention Name(s)
long-pulsed erbium YAG laser, LP NightLase
Intervention Description
LP Er:YAG applied to oral mucosa
Intervention Type
Device
Intervention Name(s)
SMOOTH mode Er:YAG
Other Intervention Name(s)
SMOOTH mode erbium YAG laser, SMOOTH mode NightLase
Intervention Description
SMOOTH mode Er:YAG applied to oral mucosa
Intervention Type
Device
Intervention Name(s)
sham
Other Intervention Name(s)
placebo
Intervention Description
Er:YAG laser applied to oral mucosa with no energy
Primary Outcome Measure Information:
Title
NightLase Snoring Questionnaire-Question 1: Snoring severity change from baseline
Description
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
Secondary Outcome Measure Information:
Title
Change from baseline in snoring value
Description
Snorelab software used to record snoring
Time Frame
1 month
Title
Change from baseline in snoring value
Description
Snorelab software used to record snoring
Time Frame
3 months
Title
Change from baseline in snoring value
Description
Snorelab software used to record snoring
Time Frame
12 months
Title
Change from baseline in snoring value
Description
Snorelab software used to record snoring
Time Frame
6 months
Title
NightLase Snoring Questionnaire-Question 1: Snoring severity change from baseline
Description
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
Title
NightLase Snoring Questionnaire-Question 1: Snoring severity change from baseline
Description
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
Title
NightLase Snoring Questionnaire-Question 1: Snoring severity change from baseline
Description
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
Title
NightLase Snoring Questionnaire change from baseline
Description
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
Title
NightLase Snoring Questionnaire change from baseline
Description
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
Title
NightLase Snoring Questionnaire change from baseline
Description
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
Title
NightLase Snoring Questionnaire change from baseline
Description
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
Title
Change in EpWorth somnolence scale from baseline
Description
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
Title
Change in EpWorth somnolence scale from baseline
Description
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
Title
Change in EpWorth somnolence scale from baseline
Description
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
Title
Change in EpWorth somnolence scale from baseline
Description
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
Title
Change in Quality of life Questionnaire score from baseline
Description
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
Title
Change in Quality of life Questionnaire score from baseline
Description
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
Title
Change in Quality of life Questionnaire score from baseline
Description
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
Title
Change in Quality of life Questionnaire score from baseline
Description
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
Title
Change in Apnea - Hypopnea Index (AHI) from baseline.
Description
Measured by polysomnography.
Time Frame
3 months
Title
Change in O2 saturation (%) from baseline.
Description
Measured by polysomnography.
Time Frame
3 months
Title
Change in snoring time (mean duration of episode in s) from baseline.
Description
Measured by polysomnography.
Time Frame
3 months
Title
Change in percentage snoring time of total sleep time (%) from baseline.
Description
Measured by polysomnography.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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%).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luis Monteiro, DMD, PhD
Phone
+351 919120226
Email
luis.monteiro@iucs.cespu.pt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Monteiro, DMD, PhD
Organizational Affiliation
Instituto Universitário de Ciências da Saude, CESPU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Universitário de Ciências da Saude, CESPU
City
Porto
ZIP/Postal Code
4585-116
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Monteiro
Phone
+351 919120226
Email
luis.monteiro@iucs.cespu.pt

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Tial of Er:YAG Laser Snoring Treatment

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