scholarly journals Modafinil/armodafinil in obstructive sleep apnoea: a systematic review and meta-analysis

2016 ◽  
Vol 47 (5) ◽  
pp. 1420-1428 ◽  
Author(s):  
Julia L. Chapman ◽  
Andrew Vakulin ◽  
Jan Hedner ◽  
Brendon J. Yee ◽  
Nathaniel S. Marshall
Keyword(s):  
Adverse Events ◽  
Obstructive Sleep Apnoea ◽  
Meta Analysis ◽  
Safety Data ◽  
Sleep Apnoea ◽  
European Medicines Agency ◽  
Controlled Trials ◽  
Serious Adverse Events ◽  
Obstructive Sleep ◽  
Randomised Controlled

Modafinil is used internationally to treat residual sleepiness despite continuous positive airway pressure in obstructive sleep apnoea (res-OSA). In 2011, the European Medicines Agency removed the indication based on an unfavourable risk–benefit profile in two trials for efficacy and all accumulated safety data. We performed a meta-analysis of all randomised controlled trials of modafinil (or armodafinil) in res-OSA to quantify efficacy and safety.We systematically searched and assessed studies from major databases, conferences and trials registries to find randomised, placebo-controlled trials of modafinil/armodafinil for ≥2 weeks in adult res-OSA treating sleepiness.We analysed 10 of the 232 articles identified that met inclusion criteria (1466 patients). Modafinil/armodafinil improved the Epworth Sleepiness Scale score (2.2 points, 95% CI 1.5–2.9) and the Maintenance of Wakefulness Test over placebo (3 min, 95% CI 2.1–3.8 min). Modafinil/armodafinil tripled adverse events and doubled adverse events leading to withdrawal but did not increase serious adverse events (hospitalisations or death).Modafinil and armodafinil improve subjective and objective daytime sleepiness in res-OSA. We believe our analysis is a fairer analysis of the risk–benefit profile of this indication. Clinicians may want to use this data to balance the risks and benefits on a case-by-case basis with their patients.

scholarly journals Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis

2019 ◽  
Vol 54 (18) ◽  
pp. 1073-1080 ◽  
Author(s):  
Andre Niemeijer ◽  
Hans Lund ◽  
Signe Nilssen Stafne ◽  
Thomas Ipsen ◽  
Cathrine Luhaäär Goldschmidt ◽  
...  
Keyword(s):  
Systematic Review ◽  
Relative Risk ◽  
Adverse Events ◽  
Exercise Therapy ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Control Group ◽  
Controlled Trials ◽  
Serious Adverse Events ◽  
Randomised Controlled

ObjectiveTo evaluate the relative risk (RR) of serious and non-serious adverse events in patients treated with exercise therapy compared with those in a non-exercising control group.DesignSystematic review and meta-analysis.Data sourcesPrimary studies were identified based on The Cochrane Database of Systematic Reviews investigating the effect of exercise therapy.Eligibility criteriaAt least two of the authors independently evaluated all identified reviews and primary studies. Randomised controlled trials were included if they compared any exercise therapy intervention with a non-exercising control. Two authors independently extracted data. The RR of serious and non-serious adverse events was estimated separately.Results180 Cochrane reviews were included and from these, 773 primary studies were identified. Of these, 378 studies (n=38 368 participants) reported serious adverse events and 375 studies (n=38 517 participants) reported non-serious adverse events. We found no increase in risk of serious adverse events (RR=0.96 (95%CI 0.90 to 1.02, I2: 0.0%) due to exercise therapy. There was, however, an increase in non-serious adverse events (RR=1.19 (95%CI 1.09 to 1.30, I2: 0.0%). The number needed to treat for an additional harmful outcome for non-serious adverse events was 6 [95%CI 4 to 11).ConclusionParticipating in an exercise intervention increased the relative risk of non-serious adverse events, but not of serious adverse events. Exercise therapy may therefore be recommended as a relatively safe intervention.PROSPERO registration numberCRD42014014819.

scholarly journals Weight loss surgery for obstructive sleep apnoea with obesity in adults: a systematic review and meta-analysis protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e020876 ◽  
Author(s):  
Zhiyong Dong ◽  
Brian Y Hong ◽  
Ashley M Yu ◽  
John Cathey ◽  
Sheikh Mohammed Shariful Islam ◽  
...  
Keyword(s):  
Systematic Review ◽  
Weight Loss ◽  
Obstructive Sleep Apnoea ◽  
Weight Loss Surgery ◽  
Meta Analysis ◽  
Upper Airway ◽  
Sleep Apnoea ◽  
Controlled Trials ◽  
Obstructive Sleep

IntroductionObstructive sleep apnoea (OSA) is caused by complete or partial obstruction of the upper airway resulting in repeated episodes of interrupted or shallow breaths. OSA is associated with significant morbidity and mortality. The prevalence is estimated to range from 3% to 7% in the general population but may be much higher. Several studies show that weight loss or bariatric surgery may have a role in treating OSA. The aim of this systematic review is to assess the safety and efficacy of randomised controlled trials (RCTs) of weight loss surgery for adults with OSA and comorbid obesity.Methods and analysisA search of the Cochrane Central Register of Controlled Trials, PubMed, EMBASE and two major Chinese biomedical databases will be performed to identify related trials published as of October 2018. This study will include RCTs, comparing different types of weight loss surgery for OSA with obesity or weight loss surgery for OSA with obesity with other upper airway surgeries. The primary outcomes that will be measured are apnoea–hypopnoea index, excess weight loss and in-hospital mortality. The secondary outcomes will include duration of hospital stay, neck circumference, reoperation, waist circumference, body mass index, Epworth Sleepiness Scale score, overt complications (eg, gastric fistula, bleeding, delayed gastric emptying, wound infection), quality of life, quality of sleep and/or functionality. The systematic review will be conducted according to the recommendations as outlined by the Cochrane collaboration.Ethics and disseminationThe systematic review and meta-analysis will include published data available online and thus ethics approval will not be required. The findings will be disseminated and published in a peer-reviewed journal. Review updates will be conducted if there is new evidence that may cause any change in review conclusions. Any changes to the study protocol will be updated in the PROSPERO trial registry accordingly.PROSPERO registration numberCRD42017081743.

Endocrine responses during CPAP withdrawal in obstructive sleep apnoea: data from two randomised controlled trials

Thorax ◽  
2019 ◽  
Vol 74 (11) ◽  
pp. 1102-1105
Author(s):  
Sira Thiel ◽  
Sarah R Haile ◽  
Mirko Peitzsch ◽  
Esther I Schwarz ◽  
Noriane A Sievi ◽  
...  
Keyword(s):  
Obstructive Sleep Apnoea ◽  
Randomised Controlled Trials ◽  
Sleep Apnoea ◽  
Controlled Trials ◽  
Short Term ◽  
Link Type ◽  
Obstructive Sleep ◽  
Cardiometabolic Markers ◽  
Randomised Controlled ◽  
Pituitary Adrenal Axis

The aim of this investigation was to elucidate the effect of CPAP withdrawal on neurometabolic and cardiometabolic markers in patients with obstructive sleep apnoea. We evaluated 70 patients (mean age 61±10 years, 82% men) treated with CPAP in two 2-week, parallel, randomised controlled trials. CPAP withdrawal resulted in elevated 3,4-dihydroxyphenylglycol, norepinephrine and cortisol after 2 weeks of CPAP withdrawal; however, no statistically significant changes of the renin–angiotensin–aldosterone system (RAAS) determinants were documented. In summary, CPAP withdrawal may be more prominently linked to short-term increases in sympathetic activation than hypothalamic–pituitary–adrenal axis or RAAS activation. ClinicalTrials.gov Identifier: NCT02493673 and NCT02050425.

scholarly journals Osteopathic Manipulation of the Sphenopalatine Ganglia Versus Sham Manipulation, in Obstructive Sleep Apnoea Syndrom: A Randomised Controlled Trial

2021 ◽  
Vol 11 (1) ◽  
pp. 99
Author(s):  
Valérie Attali ◽  
Olivier Jacq ◽  
Karine Martin ◽  
Isabelle Arnulf ◽  
Thomas Similowski
Keyword(s):  
Adverse Events ◽  
Nasal Obstruction ◽  
Obstructive Sleep Apnoea ◽  
Sleep Apnoea ◽  
Obstructive Sleep Apnoea Syndrome ◽  
Upper Airways ◽  
Osteopathic Manipulation ◽  
Obstructive Sleep ◽  
Significant Difference ◽  
Randomised Controlled

(1) Background: osteopathic manipulation of the sphenopalatine ganglia (SPG) blocks the action of postganglionic sensory fibres. This neuromodulation can reduce nasal obstruction and enhance upper airway stability. We investigated the manipulation of the SPG in 31 patients with obstructive sleep apnoea syndrome (OSAS); (2) Methods: Randomised, controlled, double-blind, crossover study. Participants received active (AM), then sham manipulation (SM), or vice versa. The primary endpoint was apnoea-hypopnoea index (AHI). Secondary endpoints were variation of nasal obstruction evaluated by peak nasal inspiratory flow (PNIF) and upper airways stability evaluated by awake critical closing pressure [awake Pcrit]), at 30 min and 24 h. Schirmer’s test and pain were assessed immediately post-manipulation. Tactile/gustatory/olfactory/auditory/nociceptive/visual sensations were recorded. Adverse events were collected throughout. (3) Results: SPG manipulation did not reduce AHI (p = 0.670). PNIF increased post-AM but not post-SM at 30 min (AM-SM: 18 [10; 38] L/min, p = 0.0001) and 24 h (23 [10; 30] L/min, p = 0.001). There was no significant difference on awake Pcrit (AM-SM) at 30 min or 24 h). Sensations were more commonly reported post-AM (100% of patients) than post-SM (37%). Few adverse events and no serious adverse events were reported. (4) Conclusions: SPG manipulation is not supported as a treatment for OSAS but reduced nasal obstruction. This effect remains to be confirmed in a larger sample before using this approach to reduce nasal congestion in CPAP-treated patients or in mild OSAS.

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