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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03947424
Other study ID # 16/CE-IUCS/2018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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%).

Study Design


Related Conditions & MeSH terms


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
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