研究目的
To verify the effects of low-level laser therapy (LLLT) on obstructive sleep apnea (OSA), when applied to the soft palate and on the tongue base.
研究成果
The researchers hope to identify whether there will be a decrease in the AHI by the polysomnography measurements when applying an 808 nm infrared laser photobiomodulation by the Therapy Plus equipment. These measurements will be performed prior to, and after, the 16 treatment sessions. At the primary endpoints and at the secondary endpoints, the researchers expect to verify a decrease in apnea, as well as in the hypopnea index and snoring, with improvements in the autonomic and hemodynamic control of the subjects with OSA. Finally, the study expects to verify improvements in sleep and in the patients’ quality of life.
研究不足
The limitations of this study may be related to the lifestyle habits and the routines of the participants. These procedures can affect the results, as a consequence of their daily stress, their food, their cosmetics use, and their photo exposures.
1:Experimental Design and Method Selection:
A clinical, randomized, comparative, and blind study with 36 patients randomized into 2 treatment groups: LLLT treatment or placebo (C). The study will be implemented over 2 months, divided into 16 sessions, 2 times a week.
2:Sample Selection and Data Sources:
Individuals of both sexes aged 30 to 60 years old who are sedentary and that present a high risk of OSA by the Berlin questionnaire.
3:List of Experimental Equipment and Materials:
Therapy Plus NS 13678 Laser, polysomnography equipment, bioimpedance for body composition measurements.
4:Experimental Procedures and Operational Workflow:
The LLLT group will receive applications at 8 points on the soft palate and on the base of the tongue for 8 seconds for each point. The applications of LLLT will occur twice a week, with a minimum interval of 2 days between the applications for 2 months. The C group will have similar applications, but with the device turned off.
5:Data Analysis Methods:
The Shapiro-Wilk test will be used to test the normality of the data. The descriptive data will be presented in relative frequency, with measures of a central tendency and dispersion. The ANOVA test for the independent variables, followed by Bonferroni post-hoc test, will be used for the inferential analysis.
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