Clinical Tial of Er:YAG Laser Snoring Treatment

NCT ID: NCT03947424

Last Updated: 2023-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2024-05-01

Brief Summary

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

Detailed Description

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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).

Conditions

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Snoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three groups; laser (LP), laser (SMOOTH), control (sham)
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Experimental 1

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

Group Type EXPERIMENTAL

LP Er:YAG

Intervention Type DEVICE

LP Er:YAG applied to oral mucosa

Experimental 2

Fotona SMOOTH mode Er:YAG laser snoring treatment.

Group Type EXPERIMENTAL

SMOOTH mode Er:YAG

Intervention Type DEVICE

SMOOTH mode Er:YAG applied to oral mucosa

Control

Sham laser snoring treatment with no energy applied.

Group Type SHAM_COMPARATOR

sham

Intervention Type DEVICE

Er:YAG laser applied to oral mucosa with no energy

Interventions

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LP Er:YAG

LP Er:YAG applied to oral mucosa

Intervention Type DEVICE

SMOOTH mode Er:YAG

SMOOTH mode Er:YAG applied to oral mucosa

Intervention Type DEVICE

sham

Er:YAG laser applied to oral mucosa with no energy

Intervention Type DEVICE

Other Intervention Names

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long-pulsed erbium YAG laser LP NightLase SMOOTH mode erbium YAG laser SMOOTH mode NightLase placebo

Eligibility Criteria

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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%).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Luis Monteiro

OTHER

Sponsor Role lead

Responsible Party

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Luis Monteiro

DMD, Phd, Auxiliar Professor at the IUCS in Periodontal Surgical Clinic, Oral Pathology and Biopathology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Luis Monteiro, DMD, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Universitário de Ciências da Saude, CESPU

Locations

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Instituto Universitário de Ciências da Saude, CESPU

Porto, , Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Luis Monteiro, DMD, PhD

Role: CONTACT

+351 919120226

Facility Contacts

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Luis Monteiro

Role: primary

+351 919120226

Other Identifiers

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16/CE-IUCS/2018

Identifier Type: -

Identifier Source: org_study_id

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