scholarly journals Mandibular Advancement Appliances efficacy on Sleep Disordered Breathing in Children: a Randomised Controlled Trial

2017 ◽  
Vol 26 ◽  
pp. 8-8 ◽  
Thorax ◽  
2018 ◽  
Vol 74 (3) ◽  
pp. 282-290 ◽  
Author(s):  
David J Berlowitz ◽  
Rachel Schembri ◽  
Marnie Graco ◽  
Jacqueline M Ross ◽  
Najib Ayas ◽  
...  

RationaleHighly prevalent and severe sleep-disordered breathing caused by acute cervical spinal cord injury (quadriplegia) is associated with neurocognitive dysfunction and sleepiness and is likely to impair rehabilitation.ObjectiveTo determine whether 3 months of autotitrating CPAP would improve neurocognitive function, sleepiness, quality of life, anxiety and depression more than usual care in acute quadriplegia.Methods and measurementsMultinational, randomised controlled trial (11 centres) from July 2009 to October 2015. The primary outcome was neurocognitive (attention and information processing as measure with the Paced Auditory Serial Addition Task). Daytime sleepiness (Karolinska Sleepiness Scale) was a priori identified as the most important secondary outcome.Main results1810 incident cases were screened. 332 underwent full, portable polysomnography, 273 of whom had an apnoea hypopnoea index greater than 10. 160 tolerated at least 4 hours of CPAP during a 3-day run-in and were randomised. 149 participants (134 men, age 46±34 years, 81±57 days postinjury) completed the trial. CPAP use averaged 2.9±2.3 hours per night with 21% fully ‘adherent’ (at least 4 hours use on 5 days per week). Intention-to-treat analyses revealed no significant differences between groups in the Paced Auditory Serial Addition Task (mean improvement of 2.28, 95% CI −7.09 to 11.6; p=0.63). Controlling for premorbid intelligence, age and obstructive sleep apnoea severity (group effect −1.15, 95% CI −10 to 7.7) did not alter this finding. Sleepiness was significantly improved by CPAP on intention-to-treat analysis (mean difference −1.26, 95% CI −2.2 to –0.32; p=0.01).ConclusionCPAP did not improve Paced Auditory Serial Addition Task scores but significantly reduced sleepiness after acute quadriplegia.Trial registration numberACTRN12605000799651.


BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e033889
Author(s):  
Rui Wang ◽  
Jessie P. Bakker ◽  
Ronald D. Chervin ◽  
Susan L. Garetz ◽  
Fauziya Hassan ◽  
...  

IntroductionMild obstructive sleep-disordered breathing (oSDB), characterised by habitual snoring without frequent apnoeas and hypopnoeas on polysomnography, is prevalent in children and commonly treated with adenotonsillectomy (AT). However, the absence of high-level evidence addressing the role of AT in improving health and behavioural outcomes has contributed to significant geographical variations in care and potential for surgery to be both overused and underused.Methods and analysisThe Pediatric Adenotonsillectomy Trial for Snoring (PATS) is a single-blinded, multicentre randomised controlled trial designed to evaluate the effect of AT in treating mild oSDB. Four hundred sixty eligible children, aged 3.0–12.9 years old, will be randomised to either early adenotonsillectomy or to watchful waiting with supportive care (WWSC) with a 1:1 ratio. The study’s coprimary endpoints are (1) change from baseline in executive behaviour relating to self-regulation and organisation skills as measured by the Behavioural Rating Inventory of Executive Function (BRIEF) Global Composite Score (GEC); and (2) change from baseline in vigilance as measured on the Go-No-Go (GNG) signal detection parameter (d-prime). A mixed effects model will be used to compare changes in the BRIEF GEC score and GNG score at 6 and 12 months from baseline between the AT arm and the WWSC arm.Ethics and disseminationThe study protocol was approved by the institutional review board (IRB) at Children’s Hospital of Philadelphia (CHOP) on 3 October 2014 (14–0 11 214). The approval of CHOP as the central IRB of record was granted on 29 February 2016. The results will be published in peer-reviewed journals and presented at academic conferences. The data collected from the PATS study will be deposited in a repository (National Sleep Research Resource, sleepdata.org) after completion of the study to maximise use by the scientific community.Trial registration numberNCT02562040; Pre-results.


2018 ◽  
Vol 71 ◽  
pp. 9-17 ◽  
Author(s):  
Ghassan Idris ◽  
Barbara Galland ◽  
Christopher John Robertson ◽  
Andrew Gray ◽  
Mauro Farella

Thorax ◽  
2014 ◽  
Vol 69 (10) ◽  
pp. 938-945 ◽  
Author(s):  
Timothy G Quinnell ◽  
Maxine Bennett ◽  
Jake Jordan ◽  
Abigail L Clutterbuck-James ◽  
Michael G Davies ◽  
...  

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