Evidence map›Paper›PMID 37349132›Full record

Trial reportBMJ open respiratory research2023

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, Sandra Inglés, Rafaela Vaca, José Cordero-Guevara, Joaquín Durán-Carro, Jorge Ullate, Jordi Rigau, Joaquin Durán-Cantolla, Spanish Sleep Network

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open respiratory research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 40% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 1 country.

Laura Hidalgo-ArmasSleep Disorders Research Group, Bioaraba Health Research Institute, Vitoria, Spain lauhidalgo92@gmail.com.
Sandra InglésSleep Disorders Research Group, Bioaraba Health Research Institute, Vitoria, Spain.
Rafaela VacaCIBER of Respiratory Diseases (CibeRes), ISCIII, Madrid, Spain.
José Cordero-GuevaraEpidemiology and Public Health Research Group, Bioaraba Health Research Institute, Vitoria-Gasteiz, Spain.
Joaquín Durán-CarroSleep Disorders Research Group, Bioaraba Health Research Institute, Vitoria, Spain.
Jorge UllateSleep Disorders Research Group, Bioaraba Health Research Institute, Vitoria, Spain.ORCID 0000-0003-1087-1232
Jordi RigauResearch, Development and Innovation Director, SIBEL S.A.U, Barcelona, Spain.
Joaquin Durán-CantollaHonorific Professor of the Medicine Department, UPV/EHU School of Medicine, Vitoria, Spain.
Spanish Sleep Network
BioCruces Health research Institute · ESInstituto de Salud Carlos III · ESUniversitat de Barcelona · ESUniversity of the Basque Country · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

methodsA 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.

resultsThe 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.

conclusionHigh 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.

Indexed as

ForeheadSleep Apnea, ObstructiveHumansPatient CompliancePatient SatisfactionPersonal SatisfactionPolysomnographySleep apnoea

Identifiers

PMID37349132
PMCPMC10314629
OpenAlexW4381716110

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.