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Issue 136 – 2017

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Welcome to the May issue of Respiratory Research Review, with the topic of sleep. As in the past, this is only a snapshot of the exciting research published over the last year. The more interested reader may wish to study Sleep Medicine Research Review edited by my colleague A/Prof Alistair Neill, always an enjoyable read.Disruptive technology is reaching sleep research. The accepted gold standard sleep study is a supervised polysomnography, which is a rather resource-intensive modality available only for a minority of patients. Pragmatically, and with an increasing evidence base, many of us use sleep studies with limited channels (Ann Intern Med). At the other end of the spectrum is a rapidly growing market of sleep tracking and wearable technology. Colleagues from the University of Michigan present a fascinating evaluation of 80 different devices, several with validation studies versus polysomnography. I encourage you to flick through this review summarising the plethora of wearable devices and the clinical opportunities these will bring. Particularly fascinating is the opportunity for crowd-sourced research funding for investigations that were previously unsolvable because of funding limitation through traditional channels. When a company called Dream:ON was calling for consumer participation to explore research on dream manipulation and sleep spindle detection, they recruited more than 100,000 volunteers via their app on the first day in 2012. Stanford’s CV study recruited more than 10,000 participants via the Apple Research Kit within the first 24 hours.

Just in case you got lost in the discussion on sleep apnoea and cardiometabolic risk, you may wish to read the great review from Camilla Hoyos, Luciano Drager and Sanjay Patel. Lancet Respir Med published a comprehensive review on the clinical relevance and practice approaches to the management of mild OSA (obstructive sleep apnoea), defined as patients with an AHI (apnoea-hypopnoea index) 5–15. And, our Australian colleagues Simon Joosten, Garun Hamilton and Matthew Naughton published one of the leading articles in the Chest sleep week on the impact of weight loss in the management of OSA. Finally, Eur Respir J published the taskforce report on the ‘Principles of practice parameters for the treatment of sleep-disordered breathing in the elderly and frail elderly: the consensus of the International Geriatric Sleep Medicine Task Force’.

Many readers are affected by shift work, which forcefully interrupts the normal sleep pattern. Göran Kecklund and John Axelsson present a great state of the art review in the BMJ on the ‘Health consequences of shift work and insufficient sleep’. They explore which aspects of shift work, like the altered light exposure, the altered food/dietary pattern, the altered sleep pattern and altered behaviours, may have the biggest impact on the circadian disruption, disturbed sleep, risky behaviours and psychosocial stress. They come up with a pragmatic figure and table on organisational and individual countermeasures, such as favourable scheduling like forward rotation, sleep recovery strategies including napping, pharmacological aids like caffeine, melatonin or modafinil, light adaptation techniques and the limitation of night eating.

Thank you for the feedback and comments and we hope you enjoy the selection for May 2017.

Kind regardsProfessor Lutz Beckertlutzbeckert@researchreview.co.nz

RespiratoryResearch Review™

‘NoSAS’ for SDB screening

Polysomnography vs. limited-channel studies in OSA

CPAP improves QOL in women with OSA

OSA increases occupational injuries

Reported need for sleep and sleepiness while driving

Fixed-pressure vs. auto-adjusting CPAP in OSA

CPAP for preventing CV events in OSA

Motivational enhancement increases CPAP adherence

Transcutaneous electrical stimulation for OSA

CBT for insomnia in peri/postmenopausal women

Abbreviations used in this issueAHI = apnoea-hypopnoea indexBMI = body mass indexBP = blood pressureCBT = cognitive behavioural therapyCPAP = continuous positive airway pressureCV = cardiovascularESS = Epworth Sleepiness ScaleOSA = obstructive sleep apnoeaQOL = quality of lifeRCT = randomised controlled trialSDB = sleep-disordered breathing

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Physician decision making and clinical outcomes with laboratory polysomnography or limited-channel sleep studies for obstructive sleep apneaAuthors: Chai-Coetzer CL et al.

Summary: This noninferiority RCT included patients aged 25–80 years with suspected OSA, for whom sleep study information was disclosed to sleep physicians at one of the following three levels: 1) polysomnography data (n=135); 3) airflow, thoracoabdominal bands, body position, electrocardiography and oxygen saturation (n=136); or 4) oxygen saturation and heart rate (n=135). Noninferiority was confirmed between levels 3 and 4 versus level 1 for change in Functional Outcomes of Sleep Questionnaire score, and between level 3 versus level 1 for change in ESS (Epworth Sleepiness Scale) score (inconclusive for level 1 versus level 4). Compared with level 1, level 4 was associated with less improvement in Sleep Apnea Symptoms Questionnaire score (–17.8 vs. –24.7 [p=0.018]), less CPAP use (4.5 vs. 5.3 hours per night [p=0.04]) and lower physician diagnostic confidence (p=0.003).

Comment: If you did wish to investigate a patient with possible sleep apnoea, which test is the best? Our Australian colleagues present the results of a prospective, multicentre, randomised study comparing laboratory-based polysomnography (level 1) to a potentially home-based study with fewer recordings (level 3) and to overnight oximetry (level 4). Physician confidence in data based on oximetry was low and there was also a reduction in CPAP use and a lesser improvement in daytime sleepiness. Bottom line: all three sleep tests including overnight oximetry performed similarly in improving outcomes based on the Functional Outcomes of Sleep Questionnaire.

Reference: Ann Intern Med 2017;166(5):322–40Abstract

Continuous positive airway pressure improves quality of life in women with obstructive sleep apneaAuthors: Campos-Rodriguez F et al., on behalf of the Spanish Sleep Network

Summary: Consecutive women presenting to sleep units in Spain with moderate-to-severe OSA (AHI ≥15; mean ESS score 9.8; 77.5% postmenopausal) were randomised to receive effective CPAP therapy (n=151) or conservative treatment (n=156) for 3 months. Compared with conservative treatment, CPAP was associated with significantly greater improvements in all Quebec Sleep Questionnaire QOL domains (primary endpoint), daytime sleepiness, mood state, anxiety, depression and the physical component summary of the 12-item Short Form Health Survey.

Comment: Sleep apnoea is more common in men and our evidence base is better in men. Our Spanish colleagues went out to recruit more than 300 women with moderate-to-severe sleep apnoea and randomised them to treatment with CPAP or conservative treatment only. The outcome isn’t all that surprising. Three months of treatment with CPAP improved all QOL domains, like mood, daytime sleepiness, anxiety, depression, emotions and social interactions. The longer patients used CPAP overnight, the greater the improvement. Bottom line: CPAP therapy is an effective treatment for OSA in men and women.

Reference: Am J Respir Crit Care Med 2016;194(10):1286–94Abstract

The NoSAS score for screening of sleep-disordered breathingAuthors: Marti-Soler H et al.

Summary: This derivation and validation study developed a screening tool to identify individuals at risk for SDB (sleep-disordered breathing). Participants from a Swiss population-based cohort who had undergone clinical assessment and polysomnography (n=2121) were used to build a clinical score (NoSAS) for clinically significant SDB, based on neck circumference >40cm (4 points), BMI 25–<30 kg/m2 (3 points), BMI ≥30 kg/m2 (5 points), snoring (2 points), age >55 years (4 points) and male sex (2 points). A score of ≥8 indicated a risk of clinically significant SDB (area under the curve 0.74). The NoSAS score showed an even stronger performance in the validation EPISONO cohort (area under the curve 0.81), and performed better than existing screening tools (STOP-Bang, Berlin).

Comment: We have previously covered the Lausanne population-based sleep study, HypnoLaus (Respiratory Research Review, issue 100), which recruited more than 2000 participants and performed home-based polysomnography. The authors report a simple screening score based on neck circumference, BMI, snoring and age to predict individuals at risk of clinically significant sleep apnoea with up to 80% certainty. What is particularly impressive is that it is based mainly on objective data, and sleep apnoea can be ruled out with over 90% certainty. Bottom line: this simple, easy to use clinical score may significantly reduce the number needed to be investigated for sleep apnoea.

Reference: Lancet Respir Med 2016;4(9):742–8Abstract

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Obstructive sleep apnoea and frequency of occupational injuryAuthors: Allen AJH et al.

Summary: The risk of occupational injury associated with OSA was explored in 1236 patients referred for suspected OSA. Compared with patients without OSA, those with OSA were more likely to have experienced ≥1 occupational injury during the 5 years prior to polysomnography (adjusted odds ratio 1.76 [95% CI 0.86, 3.59]), particularly an injury more likely related to reduced vigilance such as a fall or commercial motor vehicle crash (2.42 [0.085, 6.93]).

Comment: These authors used the database from British Columbia to correlate OSA in more than 1000 patients with a claim for occupational injuries. If patients with untreated OSA have decreased daytime alertness and decreased neurocognitive function, one would expect an increased number of occupational injuries. The authors postulate to identify high-risk occupational groups and consider screening, diagnostic testing and CPAP treatment. Bottom line: patients with sleep apnoea had almost twice the number of occupational injuries and almost three times the number of vigilance-related injuries in the 5 years prior to the diagnosis compared with patients without sleep apnoea.

Reference: Thorax 2016;71(7):664–6Abstract

Association between reported sleep need and sleepiness at the wheelAuthors: Quera-Salva MA et al.

Summary: For this research into sleep problems and risks when driving, 2196 highway drivers in France were interviewed in 1996 and 3545 were interviewed in 2011. Compared with the 1996 results, drivers in 2011 reported significantly shorter sleep times on both weekdays and weekends and significantly shorter optimal sleep time, with significantly more drivers feeling sleepy at the wheel and 2.5-fold more having severe sleepiness (ESS score >15).

Comment: Imagine you are driving along a French motorway, reach the toll station and while looking for money you are being approached by the highway patrol to participate in a study to explore your sleep habits. It is impressive that 80% of all drivers stopped participated, so that the authors present data on more than 5000 drivers. Compared with 1996, in 2011 more drivers took a nap, twice as many drivers had to stop because of sleepiness and 2.5-fold as many drivers had an ESS score >15. Bottom line: drivers in 2011 appear chronically sleep deprived with seven times the rate of near-miss sleepy accidents compared with 1996.

Reference: BMJ Open 2016;6(12):e012382Abstract

Fixed-pressure CPAP versus auto-adjusting CPAP: comparison of efficacy on blood pressure in obstructive sleep apnoeaAuthors: Pépin JL et al.

Summary: Patients with OSA indicated for CPAP were randomised to fixed-pressure CPAP (n=161) or auto-adjusting CPAP (n=161), with change in systolic BP at 4 months set as the primary endpoint; median CPAP use duration was 5.1 hours per night. There was no significant difference between the fixed-pressure and auto-adjusting CPAP arms for the primary endpoint in an intent-to-treat analysis (difference –1.3mm Hg [p=0.37]), but the secondary endpoint of change in 24-hour diastolic BP was greater in the fixed-pressure CPAP group (–1.7 vs. –0.5mm Hg [p=0.048]).

Comment: These French authors explore the efficacy of two modes of CPAP to reduce BP in patients with sleep apnoea. Auto-adjusting CPAP changes the delivered air pressure according to the pressure detected in the airway and tends to achieve a similar reduction in AHI compared with fixed-pressure machines. This large double-blind RCT is accompanied by a very insightful editorial that puts the study in context. Bottom line: both fixed-pressure and auto-adjusting CPAP treatments improve BP at the office. Fixed-pressure CPAP lowers the diastolic BP and mean BP over a 24-hour cycle.

Reference: Thorax 2016;71(8):726–33Abstract

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Disclaimer: This publication is not intended as a replacement for regular medical education but to assist in the process. The reviews are a summarised interpretation of the published study and reflect the opinion of the writer rather than those of the research group or scientific journal. It is suggested readers review the full trial data before forming a final conclusion on its merits.

Research Review publications are intended for New Zealand health professionals.

Independent commentary by Professor Lutz Beckert. Professor Lutz Beckert is the Head of Department of Medicine of the University of Otago, Christchurch. He is also a Respiratory Physician at Canterbury District Health Board with particular clinical interests in interstitial lung disease, pulmonary vascular disease, respiratory physiology and COPD (chronic obstructive pulmonary disease). Lutz is happy to be contacted to discuss research ideas either as a sounding board or considering future collaborations.

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CPAP for prevention of cardiovascular events in obstructive sleep apneaAuthors: McEvoy RD et al., for the SAVE Investigators and Coordinators

Summary: This study examined whether CPAP use prevented major CV events in 2717 patients aged 45–75 years with moderate-to-severe OSA and coronary or cerebrovascular disease who were randomised to usual care with or without CPAP. After a mean follow-up of 3.7 years, rates of the primary composite endpoint (death from CV causes, myocardial infarction, stroke or hospitalisation for unstable angina, heart failure or transient ischaemic attack) in the CPAP and usual care groups did not differ significantly (17% and 15.4%, respectively), and there were no significant between-group differences for the primary endpoint’s components.

Comment: The Spanish investigators of the study highlighted earlier in this issue, investigating the use of CPAP in woman with OSA, reported that the quality of life improvement was greater the longer they used CPAP overnight (Am J Respir Crit Care Med; see page 2). This study orchestrated from Adelaide recruited more than 2500 adults after coronary or cerebrovascular events and randomised them to receive CPAP or usual care. However, more than half of the patients randomised to CPAP therapy used it for <4 hours per night. In retrospect, the study may have been underpowered and better compliance may have led to further improvements. This study joins three others that didn’t show an improvement in CV or cerebrovascular events. Bottom line: CPAP therapy did not significantly prevent CV events in patients with OSA and established CV disease.

Reference: N Engl J Med 2016;375(10):919–31Abstract

Motivational enhancement for increasing adherence to CPAPAuthors: Bakker JP et al.

Summary: Patients aged 45–75 years with moderate or severe OSA (mean AHI 26.2) without marked sleepiness but with established or risk factors for CV disease were randomised to receive CPAP with (n=41) or without (n=42) motivational enhancement delivered by a psychologist during two appointments and six phone calls over 32 weeks, resulting in 14,273 nights of evaluable data. Compared with CPAP only, the inclusion of motivational enhancement was associated with 99 minutes greater adherence to CPAP each night at 6 months (p=0.003), and the improvement persisted in a subset of 52 patients who continued in the study for 12 months, with a 97 minute per night improvement in adherence in motivational enhancement recipients.

Comment: These Harvard researchers investigated the effect of motivational enhancement to increase adherence to CPAP therapy. They randomised 83 patients with severe sleep apnoea to standard care, or standard care with two appointments and six phone calls by a psychologist with the principal goal to collaboratively reduce the subjects’ ambivalence towards CPAP therapy over 32 weeks. After 6 months, patients in the standard group used CPAP for 3.3 hours per night and patients in the motivational enhancement group adhered for 4.4 hours per night. Bottom line: motivational enhancement improved CPAP adherence by 90 minutes.

Reference: Chest 2016;150(2):337–45Abstract

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1. Esbriet® (pirfenidone) Data Sheet. Dated 26 September 2016 2. PHARMAC 2017. Application for subsidy by special authority, SA1628. Available at http://www.pharmac.govt.nz/2017/01/01/SA1628.pdf. Accessed 09 January 2017.

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Esbriet (pirfenidone) 267 mg oral capsule is a Prescription Medicine indicated for the treatment of idiopathic pulmonary fibrosis ( IPF). Dosage and Administration: Please see Esbriet Data Sheet for information. Contraindications: Contraindicated in patients with a hypersensitivity to pirfenidone or any of the excipients; Patients taking fluvoxamine and patients with a history of angioedema with pirfenidone. Precautions: Hepatic Function: Elevations in ALT and AST 3 x ULN have been reported. Liver function tests should be conducted prior to and during treatment. If significant elevations occur the dose of Esbriet should be adjusted, refer to dosage guidelines in Data Sheet. Caution when used in patients with mild to moderate hepatic impairment. Photosensitivity reaction/rash: exposure to direct sunlight should be minimised during treatment and patients instructed to wear sunblock and protective clothing. Dosage adjustment or temporary discontinuation may be required, refer to dosage guidelines in Data Sheet; Angioedema: patients who develop signs or symptoms of angioedema while taking Esbriet should immediately discontinue treatment. Cigarette smoking and inducers of CYP1A2: exposure to pirfenidone was 50% less in patients who were smokers, concomitant use of strong inducers of CYP1A2 including smoking should be avoided. Pregnancy Cat B3: there are no data on the use in pregnancy. Paediatric: safety has not been established. Renal Impairment: Use with caution in patients with mild, moderate or severe renal impairment. Drug Interactions: Esbriet is contraindicated in patients taking fluvoxamine and caution should be taken in patients taking inhibitors of CYP1A2 e.g. ciprofloxacin, amiodarone, propafenone or inducers of CYP1A2 e.g. omeprazole, rifampicin. Adverse Effects: (Common only: see Data Sheet for full list): Upper respiratory tract infection; urinary tract infection; weight decreased; decreased appetite; insomnia; dizziness; somnolence; dysgeusia; lethargy; hot flush; dyspnoea; cough; productive cough; gastroesophageal reflux disease; vomiting; abdominal distension; abdominal discomfort; abdominal pain; abdominal pain upper; stomach discomfort; gastritis; constipation; flatulence; ALT increased; AST increased; gamma glutamyl transferase increased; pruritus; erythema; dry skin; rash erythematous; rash macular; rash pruritic; myalgia; arthralgia; asthenia; non-cardiac chest pain; sunburn.

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Randomised sham-controlled trial of transcutaneous electrical stimulation in obstructive sleep apnoeaAuthors: Pengo MF et al.

Summary: Thirty-six patients with OSA (median oxygen desaturation index 25.7 per hour; median AHI 28.1) were randomised to receive one night of transcutaneous electrical stimulation and one night of sham stimulation in a randomised order in this crossover trial. Active treatment was associated with an improvement in the primary outcome measure (4% oxygen desaturation index) compared with sham stimulation (median 26.9 vs. 19.5 per hour [p=0.026]), and responders (>25% reduction in oxygen desaturation index with active versus sham stimulation; 47.2%) were mostly participants with mild-to-moderate OSA for whom the oxygen desaturation index was reduced by 10.0 per hour (p<0.001) and AHI was reduced by 9.1 per hour (p=0.004). Active stimulation was well tolerated.

Comment: CPAP adherence is a perennial problem and it is important to look at treatment alternatives. We have previously reported on the success rate of the implantable stimulator to activate the hypoglossal nerve in the treatment of sleep apnoea (Respiratory Research Review, issue 100). In this paper, a group of London researchers report a randomised, sham-controlled crossover trial of continuous transcutaneous electrical stimulation of the upper airway dilator muscles in patients with sleep apnoea. The stimulation was well tolerated. Bottom line: transcutaneous electrical stimulation of the pharyngeal dilators during sleep modestly improves upper airway obstruction resulting in about four fewer desaturations per hour.

Reference: Thorax 2016;71(10):923–31Abstract

Telephone-based cognitive behavioral therapy for insomnia in perimenopausal and postmenopausal women with vasomotor symptomsAuthors: McCurry SM et al.

Summary: The MsFLASH RCT compared telephone-based CBT (cognitive behavioural therapy) for insomnia (n=53) with menopause education control (n=53) in perimenopausal or postmenopausal women aged 40–65 years with moderate insomnia symptoms and ≥2 hot flashes each day. Compared with menopause education, CBT was associated with: i) greater reductions at 8 weeks in Insomnia Severity Index and Pittsburgh Sleep Quality Index scores (9.9 vs. 4.7 points [p<0.001] and 4.0 vs. 1.4 points [p<0.001], respectively), which persisted out to 24 weeks; ii) greater proportions of women with Insomnia Severity Index scores in the ‘no insomnia’ range at 8 weeks and 24 weeks (70% vs. 24% and 84% vs. 43%, respectively); iii) greater improvements in diary-reported sleep latency, wake time and sleep efficiency; and iv) decreased hot flash interference at 8 and 24 weeks (–15.7 vs. –7.1 [p=0.03] and –22.8 vs. –11.6 [p=0.003], respectively, despite no significant between-group difference for frequency of daily hot flashes.

Comment: This is a pragmatic single-centre study comparing the efficacy of CBT therapy delivered via the telephone with an education session about menopause and women’s health in reducing insomnia. Interestingly, the researchers started out posting 20,000 postcards to eventually randomise 106 participants. The six CBT sessions covered topics like sleep scheduling, bed restriction, stimulant control, sleep cycles across the lifespan, a behavioural sleep plan, sleep hygiene and a relapse prevention plan. Control patients were offered information about menopausal symptoms including hot flashes. Bottom line: women with access to CBT delivered via the telephone significantly improved their insomnia and sleep quality.

Reference: JAMA Intern Med 2016;176(7):913–20Abstract

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