Treatment by low level LASER in the roof of the mouth in patients with snoring and sleep apnea

Not Applicable

• Conditions: Sleep Apnea; G47.3

• Registration Number: RBR-42v548
• Lead Sponsor: niversidade Nove de Julho

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Score in two or more positive categories in the Berlin Questionnaire; when performing the polysomnography examination, the apnea and hypopnea index should be greater than or equal to 15 events per hour of sleep (AHI> 15 / h).

Exclusion Criteria

Pediatric, eudaphic and elderly patients; patients with diagnosed central apnea; alcoholic patients, smokers, oncologists, pneumopathies, patients with heart disease and with hypothyroidism; pregnant women; or patients with a history of photosensitivity (allergic). Participants unable to understand and sign the TCLE.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
As a primary endpoint, the effect of low level LASER photobiomodulation therapy is expected to reduce apnea / hypopnea index. Measurements will be taken before and after the 16 sessions.

Secondary Outcome Measures

Name	Time	Method
As a secondary endpoint, the chronic effect of low level LASER photobiomodulation therapy is expected to improve collapsibility, autonomic control, hemodynamic control, and blood inflammatory markers in individuals with Obstructive Sleep Apnea. Measurements will be taken before and after the 16 sessions.