BMJ open · 2018
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.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Kotzian Stefan Thomas, Schwarzinger Angela, Haider Sandra, Saletu Bernd, Spatt Josef, Saletu Michael Timothy
Аннотация
INTRODUCTION: Meta-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 ANALYSES: Single-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 DISSEMINATION: Before 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 NUMBER: NCT02748681; Pre-results.
METHODS AND ANALYSES: Single-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 DISSEMINATION: Before 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 NUMBER: NCT02748681; Pre-results.