Luciana B M Godoy 1 , Luciana Palombini 1 , Dalva Poyares 1 , Cibele Dal-Fabbro 1 , Thaís Moura Guimarães 1 , Priscila Calixto Klichouvicz 1 , Sergio Tufik 1 , Sonia Maria Togeiro 1 Show Affiliations »
Abstract
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Objectives: To evaluate the long-term effects of an oral appliance on clinical symptoms, respiratory sleep parameters, sleep quality, and sustained attention in patients with upper airway resistance syndrome (UARS ) were compared with placebo . Methods: This study was a randomized placebo -controlled clinical trial. Thirty UARS patients were randomized in two groups: placebo and mandibular advancement device (MAD ) groups. UARS criteria were presence of sleepiness (Epworth Sleepiness Scale ≥ 10) and/or fatigue (Modified Fatigue Impact Scale ≥ 38) associated with an apnea/hypopnea index ≤ 5 and a respiratory disturbance index (RDI) > 5 events/hour of sleep, and/or flow limitation in more than 30% of total sleep time . All patients completed the Pittsburgh Sleep Quality Index (PSQI), the Functional Outcomes of Sleep Questionnaire, the Beck Anxiety and Depression Inventories, underwent full-night polysomnography, multiple sleep latency test, and Psychomotor Vigilance Test (PVT ). Evaluations were performed before and after 1.5 years of treatment. Results: RDI, number of respiratory effort-related arousal, percentage of total sleep time with flow limitation, and arousal index significantly decreased after 1.5 years of MAD treatment. PSQI total score improved, severity of depression symptoms decreased, and mean reaction time in the PVT, based on the first measurement taken at 8:00 am, significantly decreased (p = .03) at the end of the protocol. Conclusions: The MAD was effective in decreasing respiratory events in UARS patients . For UARS, 1.5 years of oral appliance therapy also improved sleep quality and sustained attention , and decreased the severity of depression symptoms . Clinical Trial: Efficacy of Oral Appliance for Upper Airway Resistance Syndrome : Randomized, Parallel, Placebo -Controlled Study, NCT02636621. © Sleep Research Society 2017. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.
RCT Entities: Population
Interventions
Outcomes
Objectives: To evaluate the long-term effects of an oral appliance on clinical symptoms, respiratory sleep parameters, sleep quality, and sustained attention in patients with upper airway resistance syndrome (UARS) were compared with placebo. Methods: This study was a randomized placebo-controlled clinical trial. Thirty UARS patients were randomized in two groups: placebo and mandibular advancement device (MAD) groups. UARS criteria were presence of sleepiness (Epworth Sleepiness Scale ≥ 10) and/or fatigue (Modified Fatigue Impact Scale ≥ 38) associated with an apnea/hypopnea index ≤ 5 and a respiratory disturbance index (RDI) > 5 events/hour of sleep, and/or flow limitation in more than 30% of total sleep time. All patients completed the Pittsburgh Sleep Quality Index (PSQI), the Functional Outcomes of Sleep Questionnaire, the Beck Anxiety and Depression Inventories, underwent full-night polysomnography, multiple sleep latency test, and Psychomotor Vigilance Test (PVT). Evaluations were performed before and after 1.5 years of treatment. Results: RDI, number of respiratory effort-related arousal, percentage of total sleep time with flow limitation, and arousal index significantly decreased after 1.5 years of MAD treatment. PSQI total score improved, severity of depression symptoms decreased, and mean reaction time in the PVT, based on the first measurement taken at 8:00 am, significantly decreased (p = .03) at the end of the protocol. Conclusions: The MAD was effective in decreasing respiratory events in UARS patients . For UARS, 1.5 years of oral appliance therapy also improved sleep quality and sustained attention, and decreased the severity of depression symptoms . Clinical Trial: Efficacy of Oral Appliance for Upper Airway Resistance Syndrome: Randomized, Parallel, Placebo-Controlled Study, NCT02636621. © Sleep Research Society 2017. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.
Entities: Disease
Species
Keywords:
Upper airway resistance syndrome; excessive daytime sleepiness; fatigue; mandibular advancement device; oral appliance therapy; sleep disordered breathing
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Year: 2017
PMID： 29045745 DOI： 10.1093/sleep/zsx175
Source DB: PubMed Journal: Sleep ISSN： 0161-8105 Impact factor: 5.849