Patient compliance and satisfaction with a new forehead device for positional obstructive sleep apnoea treatment: a post hoc analysis of a randomised controlled trial

Background The influence of body position in obstructive sleep apnoea patients is well known. A positional therapy device placed at the forehead has proven to be effective in reducing the severity of positional obstructive sleep apnoea (POSA) symptoms. The aim of the study was to evaluate patients’...

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Autores: Hidalgo-Armas, Laura, Inglés, Sandra, Vaca, Rafaela, Cordero Guevara, Jose Aurelio, Durán-Carro, Joaquín, Ullate, Jorge, Rigau, Jordi, Durán-Cantolla, Joaquín, Spanish Sleep Network
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:España
Institución:Universitat de Lleida (UdL)
Repositorio:Repositori Obert UdL
OAI Identifier:oai:repositori.udl.cat:10459.1/464262
Acceso en línea:https://doi.org/10.1136/ bmjresp-2022-001503
https://hdl.handle.net/10459.1/464262
Access Level:acceso abierto
Palabra clave:Obstructive sleep apnoea treatment
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spelling Patient compliance and satisfaction with a new forehead device for positional obstructive sleep apnoea treatment: a post hoc analysis of a randomised controlled trialHidalgo-Armas, LauraInglés, SandraVaca, RafaelaCordero Guevara, Jose AurelioDurán-Carro, JoaquínUllate, JorgeRigau, JordiDurán-Cantolla, JoaquínSpanish Sleep NetworkObstructive sleep apnoea treatmentBackground The influence of body position in obstructive sleep apnoea patients is well known. A positional therapy device placed at the forehead has proven to be effective in reducing the severity of positional obstructive sleep apnoea (POSA) symptoms. The aim of the study was to evaluate patients’ therapy compliance and satisfaction in the short term and mid-term. Methods A post hoc analysis of a randomised controlled trial was conducted using an inactive device (ID) or an active device (AD) for 3 months. The primary outcomes were device usage and the percentage of patients with good compliance (defined as device use for more than 4 hours per night and more than 70% of nights per week). Secondary outcomes included time spent with head in the supine position, patient satisfaction and side effects. Results The median duration of using the device was 6.9 hours in the ID group and 6.7 hours in the AD group (p=0.309), and the durations were similar throughout the follow-up period and from the first day of use. The percentage of patients with good compliance was similar and greater than 60% in both groups. The median time spent with head in the supine position was significantly lower in the AD group (2.9%) than in the ID group (12.4%) since the first day of treatment. Both groups showed satisfaction scores values above 8.5 (out of 10) in all items, while side effects were scarcely reported. Conclusion High device compliance was achieved in POSA patients, both in terms of device usage time and percentage of days used. Patients were highly satisfied, and the device effectively reduced the time spent with the head in the supine position from the first day of use.The Sibelmed Company provided the devices to perform the study but did not take part in the study design or management of the results. There was no economic contribution to the study by Sibelmed. This study was financed by the National Health Institute (ISCIII PI112/00243), the Health Department of the Basque Government (DSGV 2013) and the Spanish Respiratory Society (SEPAR 2014).BMJ Publishing Group2023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://doi.org/10.1136/ bmjresp-2022-001503https://hdl.handle.net/10459.1/464262reponame:Repositori Obert UdL instname:Universitat de Lleida (UdL)InglésReproducció del document publicat a https://doi.org/10.1136/ bmjresp-2022-001503BMJ Open Respiratory Research, 2023, vol. 10, núm. 1, e001503cc-by-nc (c) Laura Hidalgo-Armas et al., 2023Attribution-NoDerivatives 4.0 Internationalinfo:eu-repo/semantics/openAccesshttp://creativecommons.org/licenses/by-nc/4.0/oai:repositori.udl.cat:10459.1/4642622026-06-24T12:42:17Z
dc.title.none.fl_str_mv Patient compliance and satisfaction with a new forehead device for positional obstructive sleep apnoea treatment: a post hoc analysis of a randomised controlled trial
title Patient compliance and satisfaction with a new forehead device for positional obstructive sleep apnoea treatment: a post hoc analysis of a randomised controlled trial
spellingShingle Patient compliance and satisfaction with a new forehead device for positional obstructive sleep apnoea treatment: a post hoc analysis of a randomised controlled trial
Hidalgo-Armas, Laura
Obstructive sleep apnoea treatment
title_short Patient compliance and satisfaction with a new forehead device for positional obstructive sleep apnoea treatment: a post hoc analysis of a randomised controlled trial
title_full Patient compliance and satisfaction with a new forehead device for positional obstructive sleep apnoea treatment: a post hoc analysis of a randomised controlled trial
title_fullStr Patient compliance and satisfaction with a new forehead device for positional obstructive sleep apnoea treatment: a post hoc analysis of a randomised controlled trial
title_full_unstemmed Patient compliance and satisfaction with a new forehead device for positional obstructive sleep apnoea treatment: a post hoc analysis of a randomised controlled trial
title_sort Patient compliance and satisfaction with a new forehead device for positional obstructive sleep apnoea treatment: a post hoc analysis of a randomised controlled trial
dc.creator.none.fl_str_mv Hidalgo-Armas, Laura
Inglés, Sandra
Vaca, Rafaela
Cordero Guevara, Jose Aurelio
Durán-Carro, Joaquín
Ullate, Jorge
Rigau, Jordi
Durán-Cantolla, Joaquín
Spanish Sleep Network
author Hidalgo-Armas, Laura
author_facet Hidalgo-Armas, Laura
Inglés, Sandra
Vaca, Rafaela
Cordero Guevara, Jose Aurelio
Durán-Carro, Joaquín
Ullate, Jorge
Rigau, Jordi
Durán-Cantolla, Joaquín
Spanish Sleep Network
author_role author
author2 Inglés, Sandra
Vaca, Rafaela
Cordero Guevara, Jose Aurelio
Durán-Carro, Joaquín
Ullate, Jorge
Rigau, Jordi
Durán-Cantolla, Joaquín
Spanish Sleep Network
author2_role author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Obstructive sleep apnoea treatment
topic Obstructive sleep apnoea treatment
description Background The influence of body position in obstructive sleep apnoea patients is well known. A positional therapy device placed at the forehead has proven to be effective in reducing the severity of positional obstructive sleep apnoea (POSA) symptoms. The aim of the study was to evaluate patients’ therapy compliance and satisfaction in the short term and mid-term. Methods A post hoc analysis of a randomised controlled trial was conducted using an inactive device (ID) or an active device (AD) for 3 months. The primary outcomes were device usage and the percentage of patients with good compliance (defined as device use for more than 4 hours per night and more than 70% of nights per week). Secondary outcomes included time spent with head in the supine position, patient satisfaction and side effects. Results The median duration of using the device was 6.9 hours in the ID group and 6.7 hours in the AD group (p=0.309), and the durations were similar throughout the follow-up period and from the first day of use. The percentage of patients with good compliance was similar and greater than 60% in both groups. The median time spent with head in the supine position was significantly lower in the AD group (2.9%) than in the ID group (12.4%) since the first day of treatment. Both groups showed satisfaction scores values above 8.5 (out of 10) in all items, while side effects were scarcely reported. Conclusion High device compliance was achieved in POSA patients, both in terms of device usage time and percentage of days used. Patients were highly satisfied, and the device effectively reduced the time spent with the head in the supine position from the first day of use.
publishDate 2023
dc.date.none.fl_str_mv 2023
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://doi.org/10.1136/ bmjresp-2022-001503
https://hdl.handle.net/10459.1/464262
url https://doi.org/10.1136/ bmjresp-2022-001503
https://hdl.handle.net/10459.1/464262
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a https://doi.org/10.1136/ bmjresp-2022-001503
BMJ Open Respiratory Research, 2023, vol. 10, núm. 1, e001503
dc.rights.none.fl_str_mv cc-by-nc (c) Laura Hidalgo-Armas et al., 2023
Attribution-NoDerivatives 4.0 International
info:eu-repo/semantics/openAccess
http://creativecommons.org/licenses/by-nc/4.0/
rights_invalid_str_mv cc-by-nc (c) Laura Hidalgo-Armas et al., 2023
Attribution-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv BMJ Publishing Group
publisher.none.fl_str_mv BMJ Publishing Group
dc.source.none.fl_str_mv reponame:Repositori Obert UdL
instname:Universitat de Lleida (UdL)
instname_str Universitat de Lleida (UdL)
reponame_str Repositori Obert UdL
collection Repositori Obert UdL
repository.name.fl_str_mv
repository.mail.fl_str_mv
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