Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2020
Long term oral appliance therapy decreases stress symptoms in patients with upper airway resistance syndrome.
Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02636621 (Efficacy of Oral Appliance for Upper Airway Resistance Syndrome), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Efficacy of Oral Appliance for Upper Airway Resistance Syndrome: Randomized, Parallel, Placebo, Controlled Study
Who cites it
1 citing paper in PubMed, 7 citations in OpenAlex.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
objectivesTo 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.
methodsThis 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.
resultsMean 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.
conclusionsMandibular advancement devices were effective in decreasing stress symptoms in UARS patients after 1.5 years of treatment. CLINICAL
trial registrationRegistry: ClinicalTrials.gov; Name: Efficacy of Oral Appliance for Upper Airway Resistance Syndrome; URL: https://clinicaltrials.gov/ct2/show/record/NCT02636621; Identifier: NTC02636621.
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Registered trials
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