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

Photobiomodulation by low level LASER therapy in patients with obstructive sleep apnea

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-42v548
Enrollment
Unknown
Registered
2019-06-04
Start date
2019-06-03
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

Interventions

Data collection will be performed before the first procedure and at the end of the 16th session of low level LASER, with Target sample size: 36 participants. Group 1: 18 participants will receive Trea
Device
E02.774

Sponsors

Universidade Nove de Julho
Lead Sponsor
Universidade Nove de Julho
Collaborator

Eligibility

Age
30 Years to 60 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Brazil

Contacts

Public ContactFernanda ;Fernanda Ferreira de Camargo;Ferreira de Camargo

Universidade Nove de Julho;Universidade Nove de Julho

contato@ligadosono.com.br;contato@ligadosono.com.br+55-011-985368718;11985368718

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 19, 2026