Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2018 Jan 9;8(1):e018847.
doi: 10.1136/bmjopen-2017-018847.

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

Stefan Thomas Kotzian  1 , Angela Schwarzinger  1 , Sandra Haider  1 , Bernd Saletu  2 , Josef Spatt  1 , Michael Timothy Saletu  1
Affiliations
Randomized Controlled Trial

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

Stefan Thomas Kotzian et al. BMJ Open. .

Abstract

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.

Keywords: Pap adherence; pulse transit time; sleep apnea; stroke; telemedicine; type iii polygraphy.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
An overview of the study design. AHI, apnoea-hypopnoea index; PAP, positive airway pressure; PSG, polysomnography.
See this image and copyright information in PMC

References

    1. Somers VK, White DP, Amin R, et al. . Sleep apnea and cardiovascular disease: an American heart association/american college of cardiology foundation scientific statement from the american heart association council for high blood pressure research professional education committee, council on clinical cardiology, stroke council, and council on cardiovascular nursing. in collaboration with the national heart, lung, and blood institute national center on sleep disorders research (national institutes of health). Circulation 2008;118:1080–111. 10.1161/CIRCULATIONAHA.107.189420 - DOI - PubMed
    1. Mozaffarian D, Benjamin EJ, Go AS, et al. . Heart disease and stroke statistics-2015 update: a report from the American heart association. Circulation 2015;131:434–41. - PubMed
    1. Hermann DM, Bassetti CL. Sleep-related breathing and sleep-wake disturbances in ischemic stroke. Neurology 2009;73:1313–22. 10.1212/WNL.0b013e3181bd137c - DOI - PubMed
    1. Saletu M, Nosiska D, Kapfhammer G, et al. . Structural and serum surrogate markers of cerebrovascular disease in obstructive sleep apnea (OSA): association of mild OSA with early atherosclerosis. J Neurol 2006;253:746–52. 10.1007/s00415-006-0110-6 - DOI - PubMed
    1. Saletu M, Sauter C, Lalouschek W, et al. . Is excessive daytime sleepiness a predictor of carotid atherosclerosis in sleep apnea? Atherosclerosis 2008;196:810–6. 10.1016/j.atherosclerosis.2007.01.016 - DOI - PubMed

Publication types

Associated data