Study Results
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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UNKNOWN
NA
75 participants
INTERVENTIONAL
2018-06-01
2024-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental 1
Long-pulse (LP) Er:YAG laser snoring treatment.
LP Er:YAG
LP Er:YAG applied to oral mucosa
Experimental 2
Fotona SMOOTH mode Er:YAG laser snoring treatment.
SMOOTH mode Er:YAG
SMOOTH mode Er:YAG applied to oral mucosa
Control
Sham laser snoring treatment with no energy applied.
sham
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
SMOOTH mode Er:YAG
SMOOTH mode Er:YAG applied to oral mucosa
sham
Er:YAG laser applied to oral mucosa with no energy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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%).
18 Years
ALL
No
Sponsors
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Luis Monteiro
OTHER
Responsible Party
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Luis Monteiro
DMD, Phd, Auxiliar Professor at the IUCS in Periodontal Surgical Clinic, Oral Pathology and Biopathology
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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16/CE-IUCS/2018
Identifier Type: -
Identifier Source: org_study_id
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