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4th June 2024
NICE has recommended five devices that can be used at home to diagnose and assess the severity of obstructive sleep apnoea/hypopnoea syndrome, freeing up clinician time and helping to reduce waiting lists.
The draft guidance which applies to those over the age of 16 could help the NHS identify people with the condition more easily, NICE said.
More research is needed on the home-testing devices before they can be used in children, the committee added.
Evidence should also be collected on how accurately the devices assess obstructive sleep apnoea in people with black or brown skin, NICE said.
In making the recommendations, the committee said minimal or no help is needed from a healthcare professional to use and attach the devices, which may give a clearer picture because they allow for a more natural night’s sleep.
This contrasts with current systems that have multiple wires and a cannula inserted into the nose and can require a hospital appointment for the person to be shown how to use them.
These may not be suitable for everyone depending on a person’s comorbidities, the committee noted.
Expert clinical advice provided to NICE suggested that hospital sleep testing capacity has reduced since the pandemic, creating more reliance on home testing as the primary approach to sleep diagnostics.
It is thought around 5% of the population has undiagnosed obstructive sleep apnoea hypopnoea syndrome, which is linked to hypertension, diabetes, stroke and heart disease that can shorten life expectancy.
Two of the devices are strapped to the wrist with sensors attached to the finger and chest, another has a wireless sensor attached to the throat. One of the devices is worn as a belt around the waist whilst the last one uses a wireless sensor attached to the finger to detect symptoms using oxygen saturation, body movement and pulse rate.
Some devices require internet and smartphone compatibility, but for others the data is downloaded after the designated monitoring period.
Mark Chapman, director of the Health Technologies Programme at NICE, said: ‘Having obstructive sleep apnoea can cause serious health issues which could be managed if diagnosed and treated.
‘Many people don’t even know they have this condition which is why it is important to be able to receive a diagnosis quickly and efficiently.
‘It is promising that some of the new devices could have the potential to further improve detection of sleep apnoea for people with black or brown skin, but further evidence is needed to show this.’
He added: ‘Another added benefit to these new devices includes the fact they are less invasive, more comfortable to wear, and could cut waiting times because they are easier to use, thus speeding up diagnosis and freeing up clinician time.’
The recommendations are out for consultation until 5 June, with an expected publication date of 11 September 2024.
A version of this article was originally published by our sister publication Pulse.
16th August 2023
The use of beta-blockers is associated with an increased risk of cardiovascular disease (CVD) and a trend for a higher mortality risk among patients with obstructive sleep apnoea (OSA), according to the findings from a recent study.
Researchers from University College London School of Pharmacy found that the use of beta-blocker drugs in patients with OSA increases the five-year risk of mortality and adverse cardiovascular outcomes.
In the absence of real-world evidence, the study, published in The Lancet Regional Health – Europe, investigated the impact of beta-blocker use on all-cause mortality and adverse cardiovascular outcomes in patients with OSA.
For the purposes of their analysis, the researchers turned to IQVIA Medical Research Data – a nationwide database of primary care records in the UK that contains around 6% of the total UK population in 2015. The database includes demographic and lifestyle information such as smoking and alcohol consumption, medical diagnoses and procedures, together with prescribing information.
Included patients were adults aged over 18 who had a diagnosis of OSA in their medical records. The team then compared the treatment strategies of initiating oral beta-blockers versus not starting a beta-blocker in these patients.
The outcomes of interest were all-cause mortality or a diagnosis of CVD, defined as a composite event of angina, myocardial infarction, stroke/transient ischaemic attack, heart failure or atrial fibrillation.
A total of 37,581 patients met the eligibility criteria and were followed for a median of 4.1 years.
The five-year absolute risk of all-cause mortality and CVD outcomes were 4.9% and 13.0% among beta-blocker users, compared to 4.0% and 9.4% among non-beta-blocker users, respectively.
Commenting on these findings, study lead Dr Kenneth Man said: ‘Our study underscores the urgent need for further investigation into the relationship between beta-blockers and health outcomes in OSA patients.
‘Our hope is that this information will help medical professionals make more informed decisions when treating patients with OSA.‘
This extensive study is one of the few exploring the real-world implications of medical treatment in OSA patients. It emphasises the importance of careful and continued monitoring of these patients and encourages further investigation in this field.
Further studies are anticipated to confirm these findings and delve deeper into understanding the association between beta-blocker usage and patient outcomes. Until such studies are conducted, the medical community is urged to consider the potential risks highlighted by this research when treating patients with OSA.
9th August 2023
Domiciliary transcutaneous electrical stimulation of the hypoglossal nerve could be used to reduce the severity of symptoms experienced by patients with obstructive sleep apnoea (OSA), according to the findings of recent study.
Patients treated with transcutaneous electrical stimulation showed improvements in nocturnal breathing and a significant reduction of daytime exhaustion.
The TESLA open-label phase 3 trial, which was published in eClinical Medicine and led by researchers from King’s College London and Guy’s & St Thomas’ NHS Foundation Trust, examined whether domiciliary transcutaneous electrical stimulation would control OSA and provide health benefits. Traditionally used for arthritis and during child labour, this study marked the first time the device has been used for OSA.
Participants with an apnoea-hypopnoea-index (AHI) of 5 to 35 (i.e. mild-to-severe disease) and a body mass index of 18.5 to 32, together with a documented lack of adherence to continuous positive airway pressure (CPAP) therapy, were included. Individuals were then randomised 1:1 to receive domiciliary transcutaneous electrical stimulation or usual care with ongoing CPAP therapy.
The primary outcome of the trial was the change in AHI at three months. Secondary outcomes included sleepiness – based on the Epworth Sleepiness Scale (ESS) – and the 4% oxygen desaturation index (ODI).
A total of 56 participants were enrolled and randomly assigned to domiciliary transcutaneous electrical stimulation (29 participants, of which 27 completed the trial) or usual care (27 participants) and followed for a median of three months. The two groups were similar in terms of age, gender and body mass index.
At follow-up, the AHI had improved in the transcutaneous group (p = 0.006) compared to baseline, but not in the usual care group (p = 0.69). The unadjusted group difference in the AHI was −11.5, which was statistically significant (p = 0.016). However, when adjusted for the baseline value, this difference was no longer significant (p = 0.12).
Despite this, the mean group difference in the ESS at the end of the trial was significant after adjustment for the baseline value (p = 0.020), favouring the intervention. Similarly, adjusted mean difference in ODI was also significant (p = 0.036).
Minor adverse events were found in one of the participants who developed mild headaches related to the intervention.
The authors concluded that domiciliary transcutaneous electrical stimulation for patients with OSA without significant comorbidities is feasible, safe and reduces disease severity.
Professor Joerg Steier, consultant in respiratory and sleep medicine at Guy’s & St Thomas’ and professor of respiratory and sleep medicine at King’s College London’s School of Basic and Medical Biosciences, said: ‘A TENS machine is non-invasive, has little side effects and is cheap. The TESLA trial shows us the potential of a new therapeutic option, transcutaneous electrical stimulation, and it will be interesting to see how the method can be used in clinical practice.‘
OSA is a common condition affecting up to one billion people worldwide. It is diagnosed based on several symptoms including excessive daytime sleepiness, snoring, fatigue and witnessed breathing pauses (apnoeas), gasping, or choking while sleeping. Last year, evidence emerged that OSA may be diagnosed using machine learning diffusion tensor imaging models.
24th October 2022
Machine learning diffusion tensor imaging models have the potential to screen for brain changes associated with the presence of sleep apnoea.
Two machine learning diffusion tensor imaging models were able to successfully distinguish between healthy controls and patients with obstructive sleep apnoea, according to a study by US researchers from California.
Obstructive sleep apnoea (OSA) is an extremely common condition with a 2019 study estimating that globally, 936 million adults aged 30-69 years have mild to severe disease.
OSA leads to a significant impairment in quality of life related to physical functioning, as well as causing daytime sleepiness, decreased learning skills and neuro-cognitive deficits that include impaired episodic memory, executive function, attention and visuospatial cognitive functions.
The gold standard diagnostic test for OSA is overnight polysomnography which requires a dedicated sleep laboratory and trained staff to interpret the results. In contrast, magnetic resonance imaging (MRI) and, in particular, diffusion tensor magnetic resonance imaging, has already been used to reveal how global brain mean diffusivity values are significantly reduced in OSA compared with controls.
The increased use of machine learning models with various imaging modalities, led the US researchers to wonder if a machine learning diffusion tensor imaging model might be able to detect the brain changes associated with OSA. After all, this approach had already been successfully used to identify major depressive disorder.
For the present study, the team focused to two types of machine learning models; a support vector machine (SVM) and a random forest (RF) to assess mean diffusivity maps from brain MRI scans. Both models were trained and compared for their ability to accurately identify OSA and cross-validated within the training dataset.
The researchers recruited 59 patients (mean age 50.2 years, 61% male) with OSA and who had been recently diagnosed through overnight polysomnography with at least moderate disease severity and who were also treatment naive. In addition, 18 OSA and 29 control patients who were not included in the training set and to assess the predictive accuracy of the models.
The cross-validation process showed that the accuracy of the SVM model was 0.73 whereas the RF model was 0.77, i.e. both models showed similar fitting accuracy for OSA and control data. Similarly, the area under the receiver-operator curve was 0.85 for the RF model and 0.84 for the SVM model.
The authors concluded that both the RF and SVM models were comparable for the diagnosis of OSA and suggested that either could be used as a screening tool for OSA in patients where diffusion tensor imaging data was available.
Citation
Pang Bo et al. Machine learning approach for obstructive sleep apnea screening using brain diffusion tensor imaging J Sleep Res 2022.
11th October 2021
Chronic urticaria (CU) is a recurrent skin condition characterised by hives, angioedema or both. The prevalence appears to vary across the world, with one 2020 review of studies indicating a prevalence of 1.4% in Asian, 0.5% in European and 0.1% in North American studies. The condition creates a huge burden on patients, markedly interfering with sleep, daily activities and overall quality of life. Interestingly, one study found that a quarter of patients with CU experienced sleep-related breathing disorders and in a small study of 31 patients with chronic idiopathic urticaria, 13 were diagnosed with obstructive sleep apnoea (OSA), one of whom had severe OSA.
Given that a proportion of patients with chronic urticaria have sleep-related breathing problems and even OSA, the precise nature of this relationship and whether CU and OSA are causally related remains uncertain. This led a team from the Department of Immunology and Pulmonary Medicine, San Jorge, Ecuador, to undertake a cross-sectional study among patients with CU to determine the frequency of OSA risk factors. Included patients were 18 years and over with a diagnosis of CU and all were screened using the STOP-Bang questionnaire, which is a highly sensitive screening tool for OSA. The “STOP” part of the questionnaire enquires about snoring, tiredness during the day, observed apnoea and high blood pressure, whereas the “Bang” part screens patients for a high body mass index (BMI > 35), age (> 50), neck circumference (> 40 cm) and male gender. Using STOP-Bang questionnaire, patients were categorised as low risk (scores 0 -2), intermediate risk (scores 3 – 4) and high ( scores 5 – 8). Patients deemed at intermediate risk were reclassified as high risk if they had two positive responses from the STOP part and were male and with a BMI > 35. In addition, patients completed the Urticaria Activity Score summed over 7 days (UAS7) which assesses itch severity and hive count. The USA7 categorises patients in terms of disease severity, with higher scores indicating more severe disease. Further questionnaires completed included a chronic urticaria quality of life questionnaire and the urticaria control test (UCT), which defines patients as being either poorly controlled or well-controlled.
Findings
A total of 171 patients with a mean age of 41.9 years (68.4% female) were included. The mean STOP-Bang score was 2.5 with 24% and 21% of patients classed as being at intermediate and high risk of OSA, respectively. There was a statistically significant association (Cramer’s V = 0.263, p < 0.001) between the UAS7 categories and the STOP-Bang risk categories. In fact, more than half of the subjects within the “moderate-severe” category (based on the UAS7 score) had an intermediate or high risk for moderate-to-severe OSA. There was also a significant association between UCT categories and STOP-Bang risk categories, such that 82.4% of patients with controlled urticaria had a low risk of OSA.
The authors concluded that their data suggested that a considerable proportion of patients with chronic urticaria were at intermediate to high risk for OSA, based on the STOP-Bang questionnaire. They added how further support for this conclusion came from the associations between higher disease activity and poor disease control. They called for more studies to determine the exact link between the two conditions.
Citation
Cherrez-Ojeda I et al. Chronic urticaria and obstructive sleep apnea: is there a significant association? World Allergy Org J 2021
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