STUDY OBJECTIVES: To evaluate the long-term effects of a mandibular advancement device (MAD) on stress symptoms and cognitive function in patients with upper airway resistance syndrome (UARS) compared with placebo. METHODS: This study was a randomized placebo-controlled clinical trial. Thirty UARS patients were randomized into 2 groups: placebo and MAD groups. UARS criteria were the presence of sleepiness (Epworth Sleepiness Scale ≥ 10) and/or fatigue (Modified Fatigue Impact Scale ≥ 38) associated with an apnea-hypopnea index ≤ 5 events/h and a respiratory disturbance index > 5 events/h of sleep, and/or flow limitation in more than 30% of total sleep time. All patients completed the Rey Auditory-Verbal Learning Test, the Logical Memory test, the Stroop Color Test, the Trail Making Test, the Digit Symbol Substitution Test, and Inventory of Stress Symptoms. Cognition protocol was defined based on the most used neuropsychological tests in the literature. Evaluations were performed before and after 1.5 years of treatment. RESULTS:Mean adherence to placebo and to MAD was 6.6 ± 2.6 and 6.1 ± 2.4 h/night, respectively. Side effects reported by MAD group were minor and short-term. There was no statistically significant difference in Rey Auditory-Verbal Learning Test, Logical Memory test, Stroop Color Test, Trail Making Test, and Digit Symbol Substitution Test before and after 1.5 years of treatment in both groups. Inventory of Stress Symptoms score decreased at the alert phase and the resistance phase after 1.5 years of MAD treatment compared to the placebo. CONCLUSIONS: Mandibular advancement devices were effective in decreasing stress symptoms in UARS patients after 1.5 years of treatment. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: Efficacy of Oral Appliance for Upper Airway Resistance Syndrome; URL: https://clinicaltrials.gov/ct2/show/record/NCT02636621; Identifier: NTC02636621.
RCT Entities:
STUDY OBJECTIVES: To evaluate the long-term effects of a mandibular advancement device (MAD) on stress symptoms and cognitive function in patients with upper airway resistance syndrome (UARS) compared with placebo. METHODS: This study was a randomized placebo-controlled clinical trial. Thirty UARS patients were randomized into 2 groups: placebo and MAD groups. UARS criteria were the presence of sleepiness (Epworth Sleepiness Scale ≥ 10) and/or fatigue (Modified Fatigue Impact Scale ≥ 38) associated with an apnea-hypopnea index ≤ 5 events/h and a respiratory disturbance index > 5 events/h of sleep, and/or flow limitation in more than 30% of total sleep time. All patients completed the Rey Auditory-Verbal Learning Test, the Logical Memory test, the Stroop Color Test, the Trail Making Test, the Digit Symbol Substitution Test, and Inventory of Stress Symptoms. Cognition protocol was defined based on the most used neuropsychological tests in the literature. Evaluations were performed before and after 1.5 years of treatment. RESULTS: Mean adherence to placebo and to MAD was 6.6 ± 2.6 and 6.1 ± 2.4 h/night, respectively. Side effects reported by MAD group were minor and short-term. There was no statistically significant difference in Rey Auditory-Verbal Learning Test, Logical Memory test, Stroop Color Test, Trail Making Test, and Digit Symbol Substitution Test before and after 1.5 years of treatment in both groups. Inventory of Stress Symptoms score decreased at the alert phase and the resistance phase after 1.5 years of MAD treatment compared to the placebo. CONCLUSIONS: Mandibular advancement devices were effective in decreasing stress symptoms in UARS patients after 1.5 years of treatment. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: Efficacy of Oral Appliance for Upper Airway Resistance Syndrome; URL: https://clinicaltrials.gov/ct2/show/record/NCT02636621; Identifier: NTC02636621.
Authors: Marilda E Novaes Lipp; Márcia M Bignotto Pereira; Ana Paula Justo; Thania M Gomes de Matos Journal: Span J Psychol Date: 2006-11 Impact factor: 1.264