Home polygraphic recording with telemedicine monitoring for diagnosis and treatment of sleep apnoea in stroke (HOPES Study): study protocol for a single-blind, randomised controlled trial

Abstract

IntroductionMeta-analyses report that more than 50% of patients who had a stroke suffer from moderate to severe sleep apnoea (SA), with adherence rates to positive airway pressure (PAP) therapy of only 30%. The primary objective of this study is to determine whether PAP adherence in patients who had a stroke with obstructive sleep apnoea (OSA) can be improved by a PAP training strategy during inhospital rehabilitation combined with a telemedicine monitoring system after discharge. Further objectives are (1) to compare the validity of a non-attended level-III polygraphy with that of a level-II polysomnography (PSG) in the diagnosis of SA, (2) to compare the validity of an apnoea-hypopnoea index (AHI) yielded by the PAP device with that obtained during PSG, (3) to determine changes in nocturnal systolic blood pressure (BP) due to PAP therapy with the pulse transit time (PTT) method and (4) to assess the impact of telemonitored PAP therapy on neurorehabilitation outcome parameters.Methods and analysesSingle-blind, monocentre, randomised controlled trial. It includes 55 patients who had a subacute stroke, aged 19–70 years, with moderate to severe OSA, who have undergone successful PAP training and titration at the neurorehabilitation unit. Patients are randomised to either a standard care group or a telemedicine group.PAP adherence, sleep and respiratory variables, subjective and objective sleep quality, systolic BP (PTT method) of the two groups are compared after 3 months and 1 year as well as cognitive and motor neurorehabilitation outcome parameters, quality of life and PAP satisfaction. Additionally, intranight AHI/total sleep time versus AHI/time in bed and night-to-night variability of the AHI are assessed.Ethics and disseminationBefore screening, all participants will be provided with oral and written information. The study will be disseminated by peer-reviewed publications and conference presentations.Trial registration numberNCT02748681; Pre-results.

International Consensus Statement on Obstructive Sleep Apnea

“…579 However, there is emerging data from small RCTs that HSAT can be feasibly implemented after stroke or transient ischemic attack (TIA) or even patients in a stroke rehabilitation unit. 586,587 Therefore, this population could be considered for testing with HSAT.…”

“…Subjects with significant cardiorespiratory disease, potential respiratory muscle weakness due to neuromuscular conditions, awake hypoventilation or suspicion of sleep‐related hypoventilation, chronic opioid medication use, history of stroke, or severe insomnia were excluded from most studies, and therefore a PSG is recommended over HSAT in these cases 579 . However, there is emerging data from small RCTs that HSAT can be feasibly implemented after stroke or transient ischemic attack (TIA) or even patients in a stroke rehabilitation unit 586,587 . Therefore, this population could be considered for testing with HSAT.…”

Home Sleep Apnea Testing is a Feasible and Accurate Method to Diagnose Obstructive Sleep Apnea in Stroke Patients During In-Hospital Rehabilitation

“…The study protocol of this single-blind randomized controlled trial was published recently. 11 During the HOPES project, all patients enrolled for neurological rehabilitation from April 18, 2016 to April 18, 2017 were offered HSAT studies for evaluation of OSA during their 4 to 8 weeks of in-hospital neurorehabilitation. In this study, confirmatory PSG with peripheral HSAT and central sensors was conducted on a different night a few days later, if screening with HSAT revealed an REI between 15 and 29 events/h.…”

A global consensus regarding the evaluation and management of sleepiness in obstructive sleep apnoea: results of a Delphi process

“…578 However, there is emerging data from small RCTs that HSAT can be feasibly implemented after stroke or TIA or even patients in a stroke rehabilitation unit. 585,586 Therefore, this population could be considered for testing with HSAT.…”