scholarly journals Effect of 1 month of zopiclone on obstructive sleep apnoea severity and symptoms: a randomised controlled trial

2018 ◽  
Vol 52 (1) ◽  
pp. 1800149 ◽  
Author(s):  
Sophie G. Carter ◽  
Jayne C. Carberry ◽  
Garry Cho ◽  
Lauren P. Fisher ◽  
Charlotte M. Rollo ◽  
...  
Keyword(s):  
Obstructive Sleep Apnoea ◽  
Driving Simulator ◽  
Controlled Trial ◽  
Safety Data ◽  
Clinical Trial Data ◽  
Sleep Apnoea ◽  
Double Blind ◽  
Obstructive Sleep ◽  
Single Night ◽  
Randomised Controlled

Hypnotic use in obstructive sleep apnoea (OSA) is contraindicated due to safety concerns. Recent studies indicate that single-night hypnotic use worsens hypoxaemia in some and reduces OSA severity in others depending on differences in pathophysiology. However, longer clinical trial data are lacking. This study aimed to determine the effects of 1 month of zopiclone on OSA severity, sleepiness and alertness in patients with low–moderate respiratory arousal thresholds without major overnight hypoxaemia.69 participants completed a physiology screening night with an epiglottic catheter to quantify arousal threshold. 30 eligible patients (apnoea–hypopnoea index (AHI) 22±11 events·h−1) then completed standard in-laboratory polysomnography (baseline) and returned for two additional overnight sleep studies (nights 1 and 30) after receiving either nightly zopiclone (7.5 mg) or placebo during a 1-month, double-blind, randomised, parallel trial (ANZCTRidentifier ANZCTRN12613001106729).The change in AHI from baseline to night 30 was not different between zopicloneversusplacebo groups (−5.9±10.2versus−2.4±5.5 events·h−1; p=0.24). Similarly, hypoxaemia, next-day sleepiness and driving simulator performance were not different.1 month of zopiclone does not worsen OSA severity, sleepiness or alertness in selected patients without major overnight hypoxaemia. As the first study to assess the effect of a hypnotic on OSA severity and sleepiness beyond single-night studies, these findings provide important safety data and insight into OSA pathophysiology.

scholarly journals The effect of acute morphine on obstructive sleep apnoea: a randomised double-blind placebo-controlled crossover trial

Thorax ◽  
2018 ◽  
Vol 74 (2) ◽  
pp. 177-184 ◽  
Author(s):  
Luke Rowsell ◽  
Keith K H Wong ◽  
Brendon J Yee ◽  
Danny J Eckert ◽  
Andrew A Somogyi ◽  
...  
Keyword(s):  
Controlled Release ◽  
Randomised Controlled Trial ◽  
Obstructive Sleep Apnoea ◽  
Controlled Trial ◽  
Oral Morphine ◽  
Sleep Apnoea ◽  
Response Threshold ◽  
Double Blind ◽  
Obstructive Sleep ◽  
Randomised Controlled

ObjectiveAnaesthesiology guidelines suggest that opioids worsen obstructive sleep apnoea (OSA) despite no randomised controlled trial evidence. We therefore conducted a randomised controlled trial to evaluate the effects of a common clinical dose of morphine on OSA, and to identify clinical phenotype and genotype vulnerability to opioid-respiratory depression.MethodsUnder a double-blind, randomised, crossover design, 60 male patients with OSA attended two visits to the hospital sleep laboratory, at least 1 week apart. Either 40 mg controlled-release oral morphine or placebo was administered. Awake ventilatory chemoreflex tests were performed post dose and prior to overnight polysomnography monitoring. Blood was sampled before sleep and the next morning for toxicology and genotype analyses. Sleep time with oxygen saturation (SpO2) <90% (T90) was the primary outcome.ResultsDespite a large inter-individual variability, 40 mg morphine did not worsen T90 and apnoea–hypopnoea index, and only decreased the SpO2 nadir by 1.3%. In patients with severe OSA, a lower baseline CO2ventilatory response threshold correlated with the worsening of T90, apnoea–hypopnoea index and oxygen desaturation index with morphine use. Patients with OSA and the A118G OPRM1 polymorphism of A/A and A/G had a significantly different morphine effect on awake ventilatory chemosensitivity and T90 during sleep.Conclusions40 mg oral controlled-release morphine did not worsen OSA in men, challenging traditional thinking that OSA will be worsened by opioids. Individual opioid response in patients with OSA may relate to baseline CO2 response threshold and OPRM1 genotype. Our study findings may pave the way for a precision medicine approach to avoid opioid-related risks.Trial registration numberThe Australian and New Zealand Clinical Trial Registry, ACTRN12613000858796.

scholarly journals Effects of suboptimal adherence of CPAP therapy on symptoms of obstructive sleep apnoea: a randomised, double-blind, controlled trial

2019 ◽  
Vol 55 (3) ◽  
pp. 1901526 ◽  
Author(s):  
Thomas Gaisl ◽  
Protazy Rejmer ◽  
Sira Thiel ◽  
Sarah R. Haile ◽  
Martin Osswald ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Obstructive Sleep Apnoea ◽  
Daytime Sleepiness ◽  
Controlled Trial ◽  
Final Analysis ◽  
Sleep Apnoea ◽  
Double Blind ◽  
Cpap Adherence ◽  
Obstructive Sleep ◽  
Randomised Controlled

IntroductionContinuous positive airway pressure (CPAP) is currently the treatment of choice for sleepiness in patients with obstructive sleep apnoea (OSA); however, adherence is often thought to be suboptimal. We investigated the effects of suboptimal CPAP usage on objective and subjective sleepiness parameters in patients with OSA.Material and methodsIn this 2-week, parallel, double-blind, randomised controlled trial we enrolled moderate-to-severe OSA patients with excessive pre-treatment daytime sleepiness (Epworth sleepiness scale (ESS) score >10 points) who had suboptimal CPAP adherence over ≥12 months (mean nightly usage time 3–4 h). Patients were allocated through minimisation to either subtherapeutic CPAP (“sham CPAP”) or continuation of CPAP (“therapeutic CPAP”). A Bayesian analysis with historical priors calculated the posterior probability of superiority.ResultsBetween May, 2016 and November, 2018, 57 patients (aged 60±8 years, 79% male, 93% Caucasian) were allocated in total, and 52 who completed the study (50% in each arm) were included in the final analysis. The unadjusted ESS score increase was 2.4 points (95% CI 0.6–4.2, p=0.01) in the sham-CPAP group when compared to continuing therapeutic CPAP. The probability of superiority of therapeutic CPAP over sham CPAP was 90.4% for ESS, 90.1% for systolic blood pressure and 80.3% for diastolic blood pressure.ConclusionsPatients with moderate-to-severe OSA and daytime sleepiness are still getting a substantial benefit from suboptimal CPAP adherence, albeit not as much as they might get if they adhered more. Whether a similar statement can be made for even lower adherence levels remains to be established in future trials.

scholarly journals P001 Safety, tolerability, and efficacy of 1 month of atomoxetine plus oxybutynin in obstructive sleep apnoea

2021 ◽  
Vol 2 (Supplement_1) ◽  
pp. A22-A22
Author(s):  
A Aishah ◽  
K Loffler ◽  
B Tonson ◽  
S Mukherjee ◽  
R Adams ◽  
...  
Keyword(s):  
Obstructive Sleep Apnoea ◽  
Side Effect ◽  
Vital Signs ◽  
Upper Airway ◽  
Sleep Apnoea ◽  
Side Effect Profile ◽  
Double Blind ◽  
Phone Calls ◽  
Obstructive Sleep ◽  
Single Night

Abstract Introduction Single-night studies with noradrenergic and anti-muscarinics have recently been shown to improve upper-airway function and reduce obstructive sleep apnoea (OSA) severity. This study aimed to determine the safety, tolerability, and efficacy profile of longer-term use of different doses of the noradrenergic agent atomoxetine combined with the anti-muscarinic oxybutynin (ato-oxy) in people with OSA. Methods Thirty-nine people with predominantly severe OSA received either 80/5mg ato-oxy, 40/5mg ato-oxy, 40/2.5mg ato-oxy or placebo nightly for 30 days according to a double-blind, randomised, parallel design. Safety and tolerability were assessed via weekly phone calls for adverse events, vital signs and objective measures of alertness and memory. Participants completed 3 in-laboratory sleep studies (baseline, night 1 and night 30) to assess efficacy. Results Side effects were generally mild and consistent with the known side-effect profile of each drug alone (e.g. dose-dependent increases in dry mouth with oxybutynin). Heart rate increased by night 30 in two of the drug arms versus placebo (e.g. 80/5mg ~9 beats/min, p=0.01). Blood pressure and measures of alertness and memory did not change between conditions. AHI4 and hypoxic burden decreased by ~50% in the 80/5mg arm on night 1 with similar magnitude reductions at night 30. ~50% of participants indicated willingness to continue taking the medication post-study. Discussion 1 month of nightly noradrenergic and anti-muscarinic combination therapy is generally well-tolerated with a side effect profile consistent with each agent alone. These findings also further highlight the potential to target noradrenergic and anti-muscarinic mechanisms for OSA pharmacotherapy development.

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