Clinical Tial of Er:YAG Laser Snoring Treatment

Luis Monteiro

Status: Enrolling

Conditions: Snoring

Treatments: Device: SMOOTH mode Er:YAG; Device: sham; Device: LP Er:YAG

Study type: Interventional

Funder types: Other

Identifiers

NCT03947424

16/CE-IUCS/2018

Details and patient eligibility

About

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

Full 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).

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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%).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups

Experimental 1

Experimental group

Description:

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

Treatment:

Device: LP Er:YAG

Experimental 2

Experimental group

Description:

Fotona SMOOTH mode Er:YAG laser snoring treatment.

Treatment:

Device: SMOOTH mode Er:YAG

Control

Sham Comparator group

Description:

Sham laser snoring treatment with no energy applied.

Treatment:

Device: sham

Sponsor of this trial

Lead Sponsor

Luis Monteiro