The Laryngoscope · 2017
Adjustable thermoplastic oral appliance versus positive airway pressure for obstructive sleep apnea.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАEquivalence TrialНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Ошибки и ограничения
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Banhiran Wish, Assanasen Paraya, Nopmaneejumrudlers Cherdchai, Nujchanart Nongyoaw, Srechareon Wimontip, Chongkolwatana Cheerasook, Metheetrairut Choakchai
Аннотация
OBJECTIVES/HYPOTHESIS: To compare outcomes of continuous positive airway pressure (CPAP) and the adjustable thermoplastic mandibular advancement splint (AT-MAS) for obstructive sleep apnea treatment.
STUDY DESIGN: Randomized crossover, noninferiority, tertiary center setting.
METHODS: Fifty patients with a mean age of 49.5 ± 10.6 years were enrolled. Inclusion criteria were age ≥18 years, apnea-hypopnea index (AHI) ≥5 events/hour, and oxygen saturation ≥70%. Exclusion criteria were temporomandibular joint disorders, severe periodontitis, inadequate teeth, and unstable medical diseases. Treatment intolerance was considered a failure. Two-week periods without treatment were followed by questionnaires and randomization into two groups: CPAP/AT-MAS (25) and AT-MAS/CPAP (25). After 6 weeks of intervention, questionnaires and home WatchPAT monitoring were performed. Following each 2-week washout period, patients crossed over to the other treatment followed by similar procedures. Primary outcomes involved the scores from the Functional Outcomes of Sleep Questionnaire (FOSQ). Secondary outcomes were AHI, side effects, and treatment adherence.
RESULTS: Seven patients withdrew from this study: five (AT-MAS intolerance) and two (lost follow-up). There was no significant difference among FOSQ scores, particularly on global scores, between both treatments (0.57, 95% confidential interval of difference: -0.15 to 1.29). Mean AHI decreased from pretreatment 39.2 ± 2.53 to 2.56 ± 0.49 and 12.92 ± 2.05 events/hour while using CPAP and the AT-MAS, respectively (P < .05). Most common side effects of CPAP were dry throat and inconvenience to carry, whereas those of the AT-MAS were jaw pain and excessive salivation.
CONCLUSIONS: Both devices improved short-term quality of life similarly; however, the AT-MAS was not as efficacious as CPAP on resolving sleep-test parameters. The AT-MAS might be considered only a temporary treatment alternative.
LEVEL OF EVIDENCE: 1b. Laryngoscope, 128:516-522, 2018.
STUDY DESIGN: Randomized crossover, noninferiority, tertiary center setting.
METHODS: Fifty patients with a mean age of 49.5 ± 10.6 years were enrolled. Inclusion criteria were age ≥18 years, apnea-hypopnea index (AHI) ≥5 events/hour, and oxygen saturation ≥70%. Exclusion criteria were temporomandibular joint disorders, severe periodontitis, inadequate teeth, and unstable medical diseases. Treatment intolerance was considered a failure. Two-week periods without treatment were followed by questionnaires and randomization into two groups: CPAP/AT-MAS (25) and AT-MAS/CPAP (25). After 6 weeks of intervention, questionnaires and home WatchPAT monitoring were performed. Following each 2-week washout period, patients crossed over to the other treatment followed by similar procedures. Primary outcomes involved the scores from the Functional Outcomes of Sleep Questionnaire (FOSQ). Secondary outcomes were AHI, side effects, and treatment adherence.
RESULTS: Seven patients withdrew from this study: five (AT-MAS intolerance) and two (lost follow-up). There was no significant difference among FOSQ scores, particularly on global scores, between both treatments (0.57, 95% confidential interval of difference: -0.15 to 1.29). Mean AHI decreased from pretreatment 39.2 ± 2.53 to 2.56 ± 0.49 and 12.92 ± 2.05 events/hour while using CPAP and the AT-MAS, respectively (P < .05). Most common side effects of CPAP were dry throat and inconvenience to carry, whereas those of the AT-MAS were jaw pain and excessive salivation.
CONCLUSIONS: Both devices improved short-term quality of life similarly; however, the AT-MAS was not as efficacious as CPAP on resolving sleep-test parameters. The AT-MAS might be considered only a temporary treatment alternative.
LEVEL OF EVIDENCE: 1b. Laryngoscope, 128:516-522, 2018.