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Apnealink

Manufactured by Resmed
Sourced in Australia, United States, Germany

The ApneaLink is a compact and portable diagnostic device designed for the screening and detection of sleep apnea. It records respiratory signals and oxygen levels during sleep, providing healthcare professionals with the necessary data to assess the presence and severity of sleep-disordered breathing.

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40 protocols using apnealink

1

Screening for Sleep Disordered Breathing

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SDB was assessed with the portable ApneaLink device (ResMed, Sydney, Australia) consisting of a nasal cannula and an oxygen clip to measure nasal flow and pulse oximetry. Trained study personnel instructed the participants on how to use the device at home. Several studies have validated the ApneaLink device (ResMed, Sydney, Australia) for the screening of SDB [28 (link), 29 ]. The AHI, oxygen desaturation index, mean oxygen saturation, and minimum SpO2 were assessed. The default settings of the screening device were used for the definitions of apnea, hypopnea, and desaturation: apnea was defined as a ≥80% decrease in airflow for ≥10 seconds, hypopnea as a decrease in airflow by ≥50-80% versus baseline for ≥10 seconds, and desaturation as a ≥4% decrease in oxygen saturation [27 (link)]. The cut-off for the diagnosis of SDB was an AHI ≥ 15/h. Patients with an AHI < 15/h were assumed to have no or mild SDB. An AHI ≥ 15 up to 29 was defined as moderate SDB and an AHI ≥ 30 as severe SDB [24 (link)]. A differentiation between obstructive and central sleep apnea was not possible because of the absence of a breast belt. Daytime sleepiness was assessed by means of the Epworth Sleepiness Scale (ESS), and a score of ≥11 was considered as excessive daytime sleepiness [30 (link)].
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2

Sleep Apnea Evaluation Using Type III Monitor

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After finishing a STOP-Bang questionnaire, the participants were invited to undergo type III portable monitor device (ApneaLink device; ResMed, Sydney, Australia). Yet, the monitoring was performed by the clinicians in the hospital instead of by the patients themselves at home to ensure the accuracy of operations. We recorded thoracoabdominal movement, nasal airflow, pulse oximetry, and snoring. Sleep-related breathing events were evaluated by researchers who were blinded to the results of the STOP-Bang questionnaire according to the guideline released by the American Academy of Sleep Medicine [14 (link)]. Apnea was defined as a ≥ 90% reduction of airflow from baseline for at least 10 seconds, while hypopnea was defined as ≥30% decrease of airflow lasting at least 10 seconds, associated with either an arousal or a ≥ 3% oxygen saturation decrease [14 (link)]. AHI (apnea-hypopnea index) was calculated as the mean number of apnea and hypopnea events per hour of sleep. SDB was diagnosed as AHI ≥ 5 events/h, and the severity was defined as follows: AHI ≥ 5 and <15 events/h for mild SDB, AHI ≥ 15 and <30 events/h for moderate SDB, and AHI ≥ 30 events/h for severe SDB.
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3

Home-based Sleep Apnea Assessment

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Night-time pulse oximetry with nasal flow measurement was performed using the validated ApneaLink (ResMed, San Diego, California, USA) device24 (link)
25 (link) to obtain information on night-time oxygen saturation, apnoeas and hypopnoeas. Sleep study analyses were based on automatic scoring analysis. The sleep study was performed at the patient's home. Individuals were instructed by a trained study nurse on how to put on the nasal cannula and the oximetry probe. An apnoea was defined as a reduction of nasal airflow of ≥80% compared with baseline for ≥10 s. Hypopnoea was defined as a reduction of nasal airflow of ≥30% compared with baseline followed by a simultaneous decrease in oxygen saturation ≥4%. The apnoea index was defined as the number of apnoeas per hour. The REI was defined as the number of apnoeas and hypopnoeas per hour of sleep according to the 2015 updated version of the American Academy of Sleep Medicine (AASM) criteria.26–28 (link) Subclinical sleep apnoea was defined to be present when the REI was 5, but <15 per hour. The ODI was defined as the number of oxygen desaturations ≥4% per hour of sleep.29 (link) An ODI of ≥5 per hour was considered to be abnormal. In addition to REI and ODI, mean night-time SpO2 and the per cent of total sleep time with SpO2<90% were calculated.
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4

Overnight Sleep Apnea Screening

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Participants completed an overnight screening at home using a portable sleep apnea screening device (ApneaLink, Resmed Inc. Poway, CA). Participants who had an Apnea Hypopnea Index >5 on the Apnea Link recording were excluded from the study.
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5

Portable Sleep Monitoring for OPCABG Patients

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Eligible patients were enrolled and admitted to the hospital. PG was performed before OPCABG. Each patient in the sleep monitoring center at Beijing Anzhen Hospital wore a portable sleep monitor (ApneaLink, ResMed, Australia). We used type III PG to detect airflow by nasal catheter, respiratory movement by chest belt, heart rate by electrocardiograph, and arterial oxygen saturation (SaO2) by pulse oximetry. All PG test data were analyzed by two physicians at the Sleep Center of Beijing Anzhen Hospital. In case of disagreement between the two, a third physician participated in the data analysis. Sleep apnea was defined as the cessation of airflow through the nose and mouth for > 10 s during sleep; hypopnea, a reduction of > 50% in the airflow intensity and ≥ 4% in SaO2 level during sleep. AHI was defined as the total number of apnea or hypopnea episodes per hour during sleep (i.e., AHI = total number of apnea or hypopnea episodes/total sleep duration (min) × 60). Moderate-severe OSA was defined as an AHI ≥ 15/h during a 7-h sleep. Oxygen desaturation index (ODI) ≥ 3% is the number of times that oxygen saturation decreases by > 3% per hour [6 (link)]. All moderate-severe patients were recommended for continuous positive airway pressure (CPAP) after discharge.
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6

Screening for Obstructive Sleep Apnea

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Risk for obstructive sleep apnea was first assessed via questionnaire at the phone/web screening. Then, those potential participants who did not score as high risk for obstructive sleep apnea on the phone screening completed an overnight screening at home using portable sleep apnea screening device (ApneaLink, Resmed Inc. Poway, CA). This 3 channel device includes a pulse oximeter, heart rate, respiratory effort and nasal airflow using a nasal pressure transducer. Apnea Hypopnea Index (AHI) is calculated based on events per hour of recording time. Previous studies have demonstrated this device has excellent sensitivity and specificity for AHI > 10, sensitivity 0.977 and specificity of 1.033 (link). All recordings were both visually inspected and scored using the Apnea Link software. Participants who had an Apnea Hypopnea Index >5 on the Apnea Link recording were excluded from the study.
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7

Replacing In-Lab Sleep Tests with HST

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Because of the COVID-19 pandemic, we decided to shift away from in-lab sleep tests to HST in some of our sleep-disordered-breathing patients out of a concern for safety and to avoid a delayed diagnosis of OSA. For those patients who had a comorbidity with insomnia, other sleep disorders, or major medical diseases, standard polysomnography was arranged as usual. The HST used in this study was ApneaLink® (ResMed, Sydney, Australia), which is an ambulatory sleep monitor that can detect OSA with acceptable reliability [13 (link),14 (link)]. Parameters were measured and analyzed automatically, and then they were reviewed and rescored by an experienced sleep specialist. Reports with incomplete data, such as insufficient recording time (<4 h), a signal that was too weak/sensor loss, or a chaotic signal were excluded, and those patients received new home sleep tests. Subjects received both a baseline HST and an outcome HST to be administered 1 week later under mouth-taping.
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8

Portable Sleep Apnea Evaluation Protocol

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All patients underwent an overnight sleep study after clinical stabilization during hospitalization (within 2 weeks after admission) using portable cardiorespiratory polygraphy (ApneaLink, Resmed, Australia), which was validated in the SAVE (Sleep Apnea Cardiovascular Endpoints) study.15, 16 Nasal airflow, thoracoabdominal movements, arterial oxygen saturation, and snoring episodes were recorded. An apnea was defined by an absence of airflow lasting ≥10 seconds (obstructive if thoracoabdominal movement was present and central if thoracoabdominal movement was absent). Hypopnea was defined as a reduction in airflow of >30% for ≥10 seconds and associated with a decrease in arterial oxygen saturation >4%. AHI was defined as the number of apneas and hypopneas per hour of total recording time. Recruited patients were categorized into OSA (AHI ≥15 events·h−1) and non‐OSA (AHI <15 events·h−1) groups. A minimum of 3 hours of satisfactory polygraphy signal recording was considered as a valid test. All studies were double scored manually by independent sleep technologists (J.F., X.W.). Further scoring was performed in cases of discrepancy by a senior consultant in sleep medicine (Y.W.).
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9

Sleep Disordered Breathing in Heart Failure

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As described previously in the German SchlaHF registry, assessment of SDB using a 2‐channel respiratory monitor (ApneaLink, ResMed, Australia, Sydney) was being performed in 256 centers (NCT01500759) with sufficient infrastructure to participate.9, 23 Between February 2008 and January 2011, type of SDB (OSA, CSA or coexisting OSA and CSA [OSA‐CSA]) and the occurrence of periodic breathing (proportion of CSR ≥20%) were determined in 1557 HFrEF patients using in‐lab polysomnography (Figure 1). In addition, arteriocapillary blood gases, age, body mass index (BMI), sex, left ventricular ejection fraction (LVEF), New York Heart Association (NYHA) class, heart rhythm, nocturnal dyspnea symptoms, nocturia, apnea‐hypopnea index (AHI), HF etiology, and medication were documented. Oxygen desaturation index, average oxygen saturation (mean Spo2), and minimum oxygen saturation (min Spo2) were documented in 97% of patients. The SchlaHF registry received central ethics approval from the Freiburger Ethikkomission for Germany, and all participants provided written informed consent.
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10

Sleep Disordered Breathing Evaluation

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Patients were recruited prospectively from the Centre for Sleep, at the Royal Brompton Hospital, London, UK, if they had a confirmed diagnosis of OSA (overnight respiratory polygraphy; Apnea link, ResMed, San Diego, California, US). Healthy participants were also recruited to the study from the Royal Brompton Hospital and Imperial College London staff.
The inclusion criteria for the patients with OSA were Oxygen Desaturation Index (ODI) >7.5 events/hour and for healthy participants ODI <5 events/hour. Exclusion criteria were coexisting sleep disorder, clinically diagnosed depression or anxiety disorder, prescription of psychotropic medications, or use of recreational drugs. All participants gave written informed consent, and the study was approved by National Research Ethics Services Committee South West-Cornwall and Plymouth 12/SW/0091.
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