Obstructive Sleep Apnea (OSA)
Conditions
Interventions
Patients will be monitored by a multidisciplinary team receiving information about the importance of adherence to treatment with CPAP. They will be guided to make changes in their lifestyles that incl
(ii) Anthropometric and bioimpedance assessment
(iii) Food consumption assessment (24-hour recall and 3-day food diary)
(iv) PITTSBURGH sleep quality index (PSQI-BR)
(v) EPWORTH Sleepiness Scale (ESS-BR)
WHOQOL-BREF quality of life questionnaire and (vi) Socioeconomic assessment questionnaire.
30422
1056
Sponsors
Universidade Federal de Lavras
Prefeitura Municipal de Lavras
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The study will include all patients diagnosed with OSA of any severity, participating in the Oxygen Therapy and Mechanical Ventilation Program in the municipality of Lavras during the study period that accepts to participate in the study.
Exclusion criteria
Exclusion criteria: The study will not include people who refuse to participate in the evaluations or proposed interventions, people who are involved in other programs that aim to weight loss or nutritional monitoring, with other sleep disorders, such as insomnia, restless legs syndrome or narcolepsy, shift workers nocturnal. In addition to the above, patients using large doses of probiotics will not be included commercial products consumed in the last 6 months (greater than or equal to 10^8 CFU or organisms perday) - includes tablets, capsules, lozenges, chewing gums or powders in which the probiotic is a primary component (must be discontinued and avoided for one month before the start of study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the serum concentration of C-reactive protein (hs-PCR), determined by quantification in a blood sample. Data will be collected before the beginning and at the end of each stage of the study. Therefore, data will be collected at the initial time (before supplementation – t0), after the completion of the first supplementation phase at 3 months (t3) and at the end of the second supplementation phase, at six months (t6). The data obtained will be analyzed comparing the results: (i) intragroup, (ii) intergroup and (iii) group vs time. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in the absolute score of the Pittsburgh Sleep Quality Index, determined by comparing the results collected through the application of the questionnaire before the beginning and at the end of each stage of the study. Therefore, data will be collected at the initial time (before supplementation – t0), after the completion of the first supplementation phase at 3 months (t3) and at the end of the second supplementation phase, at six months (t6). The data obtained will be analyzed comparing the results: (i) intragroup, (ii) intergroup and (iii) group vs time. ;Reduction in the absolute score of the EPWORTH Sleepiness Scale (EES-BR), determined by comparing the results collected through the application of the questionnaire before the beginning and at the end of each stage of the study. Therefore, data will be collected at the initial time (before supplementation – t0), after the completion of the first supplementation phase at 3 months (t3) and at the end of the second supplementation phase, at six months (t6). The data obtained will be analyzed comparing the results: (i) intragroup, (ii) intergroup and (iii) group vs time. ;Improvement in the consumption pattern determined by the evaluation of the 24-hour recall (REC24h) and 3-Day Food Diary (DA3). Determined by comparing the results collected through the application of dietary surveys in the initial time (before supplementation – t0) and monthly until the end of the experiment. The observed data will be evaluated in comparison between the study phases through the quantification of food components using food composition software. ;Reduction in body adiposity, determined by collecting anthropometric measurements (waist, hip, neck, abdominal circumference), as well as body composition through bioelectrical impedance. The evaluations will be at the initial time (before supplementation – t0), three months after the completion of the first supplementation phase at 3 months (t3) and at the end of the second supple | — |
Countries
Brazil
Contacts
Public ContactJoão ;Hianka Agostini;dos REis
;
Outcome results
None listed