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Randomized Controlled Trial
. 2023 Jun;10(1):e001503.
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

Laura Hidalgo-Armas  1   2 , Sandra Inglés  3 , Rafaela Vaca  4   5 , José Cordero-Guevara  6 , Joaquín Durán-Carro  3 , Jorge Ullate  3 , Jordi Rigau  7   8 , Joaquin Durán-Cantolla  9   10 ; Spanish Sleep Network
Collaborators, Affiliations
Randomized Controlled Trial

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

Laura Hidalgo-Armas et al. BMJ Open Respir Res. 2023 Jun.

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.

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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
Figure 1
(A) Median weekly device use during the follow-up period. (B) Median device use during the first 14 days of therapy. AD, active device; ID, inactive device.
Figure 2
Figure 2
(A) Percentage of patients with good compliance (>4 hours/day; >70% nights/week) during the follow-up period. *p=0.023; **p=0.01. (B) Percentage of patients with ‘optimal’ compliance (>5 hours/day; >70% nights/week) during the follow-up period. *p=0.005. AD, active device; ID, inactive device.
Figure 3
Figure 3
Median weekly percentage of days using the device during the follow-up period. AD, active device; ID, inactive device.
Figure 4
Figure 4
(A) Median weekly percentage of time patients spent with their heads in the supine position during follow-up (p<0.001 for all weeks); (B) median percentage of time patients spent with their heads in the supine position during the first 14 days of therapy (p<0.001 for all days). AD, active device; ID, inactive device.
Figure 5
Figure 5
Patient satisfaction at the end of follow-up period (12 weeks); all p values >0.05. AD, active device; ID, inactive device.
See this image and copyright information in PMC

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