NCT03947424

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

5.5 years

First QC Date

May 9, 2019

Last Update Submit

August 31, 2023

Conditions

Snoring

Keywords

laserEr:YAGNightLaseFotona SMOOTH

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (23)

  • Change from baseline in snoring value

    1 month

  • Change from baseline in snoring value

    3 months

  • Change from baseline in snoring value

    12 months

  • Change from baseline in snoring value

    6 months

  • NightLase Snoring Questionnaire-Question 1: Snoring severity change from baseline

    3 months

  • +18 more secondary outcomes

Study Arms (3)

Experimental 1

EXPERIMENTAL

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

Device: LP Er:YAG

Experimental 2

EXPERIMENTAL

Fotona SMOOTH mode Er:YAG laser snoring treatment.

Device: SMOOTH mode Er:YAG

Control

SHAM COMPARATOR

Sham laser snoring treatment with no energy applied.

Device: sham

Interventions

LP Er:YAGDEVICE

LP Er:YAG applied to oral mucosa

Also known as: long-pulsed erbium YAG laser, LP NightLase
Experimental 1
SMOOTH mode Er:YAGDEVICE

SMOOTH mode Er:YAG applied to oral mucosa

Also known as: SMOOTH mode erbium YAG laser, SMOOTH mode NightLase
Experimental 2
shamDEVICE

Er:YAG laser applied to oral mucosa with no energy

Also known as: placebo
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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%).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Universitário de Ciências da Saude, CESPU

Porto, 4585-116, Portugal

RECRUITING

MeSH Terms

Conditions

Snoring

Condition Hierarchy (Ancestors)

Respiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Luis Monteiro, DMD, PhD

    Instituto Universitário de Ciências da Saude, CESPU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Monteiro, DMD, PhD

CONTACT

+351 919120226luis.monteiro@iucs.cespu.pt

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three groups; laser (LP), laser (SMOOTH), control (sham)
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
DMD, Phd, Auxiliar Professor at the IUCS in Periodontal Surgical Clinic, Oral Pathology and Biopathology

Study Record Dates

First Submitted

May 9, 2019

First Posted

May 13, 2019

Study Start

June 1, 2018

Primary Completion

December 1, 2023

Study Completion

May 1, 2024

Last Updated

September 1, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)