Patient compliance and satisfaction with a new forehead device for positional obstructive sleep apnoea treatment: a post hoc analysis of a randomised controlled trial
- PMID: 37349132
- PMCID: PMC10314629
- DOI: 10.1136/bmjresp-2022-001503
Patient compliance and satisfaction with a new forehead device for positional obstructive sleep apnoea treatment: a post hoc analysis of a randomised controlled trial
Abstract
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.
Trial registration: ClinicalTrials.gov NCT03336515.
Keywords: Sleep apnoea.
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Conflict of interest statement
Competing interests: LH-A received funding from SIBEL to present the data at an international conference. JR is an employee at SIBEL S.A.U.
Figures
![Figure 1](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/10314629/bin/bmjresp-2022-001503f01.gif)
![Figure 2](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/10314629/bin/bmjresp-2022-001503f02.gif)
![Figure 3](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/10314629/bin/bmjresp-2022-001503f03.gif)
![Figure 4](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/10314629/bin/bmjresp-2022-001503f04.gif)
![Figure 5](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/10314629/bin/bmjresp-2022-001503f05.gif)
Similar articles
-
New forehead device in positional obstructive sleep apnoea: a randomised clinical trial.Thorax. 2021 Sep;76(9):930-938. doi: 10.1136/thoraxjnl-2020-216167. Epub 2021 Apr 22. Thorax. 2021. PMID: 33888576 Clinical Trial.
-
Positional obstructive sleep apnoea: challenging findings in consecutive patients treated with a vibrating position trainer.Acta Clin Belg. 2019 Dec;74(6):405-413. doi: 10.1080/17843286.2018.1545374. Epub 2018 Nov 15. Acta Clin Belg. 2019. PMID: 30433857
-
The sleep position trainer: a new treatment for positional obstructive sleep apnoea.Sleep Breath. 2013 May;17(2):771-9. doi: 10.1007/s11325-012-0764-5. Epub 2012 Aug 25. Sleep Breath. 2013. PMID: 22927107
-
Is the response rate of oral appliance therapy for subjects with and without position-dependent obstructive sleep apnoea different?Evid Based Dent. 2022 Sep;23(3):124-125. doi: 10.1038/s41432-022-0810-5. Epub 2022 Sep 23. Evid Based Dent. 2022. PMID: 36151292 Review.
-
Positional therapy in the management of positional obstructive sleep apnea-a review of the current literature.Sleep Breath. 2018 May;22(2):297-304. doi: 10.1007/s11325-017-1561-y. Epub 2017 Aug 29. Sleep Breath. 2018. PMID: 28852945 Review.
References
-
- Cuesta F, Arboledas G, Grupo Español de Sueño (GES) . Documento de Consenso Nacional Sobre El SAHS. Arch Bronconumol 2005;41:1–110.
Publication types
MeSH terms
Associated data
LinkOut - more resources
Full Text Sources