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Original research
New forehead device in positional obstructive sleep apnoea: a randomised clinical trial
  1. Laura Hidalgo Armas1,
  2. Sandra Ingles1,2,
  3. Rafaela Vaca3,4,
  4. Jose Cordero-Guevara5,
  5. Joaquin Duran Carro1,2,
  6. Jorge Ullate1,2,
  7. Ferran Barbé3,4,
  8. Joaquin Durán-Cantolla1,2,3,5,6
  9. on behalf of the Spanish Sleep Network
    1. 1 BioAraba, Osakidetza-Basque Health Service, Vitoria-Gasteiz, Spain
    2. 2 Sleep Unit, Osakidetza-Basque Health Service, Vitoria-Gasteiz, Spain
    3. 3 Respiratory Department, CIBERES, Madrid, Comunidad de Madrid, Spain
    4. 4 Translational Research in Respiratory Medicine, IRBLLEIDA, Lleida, Spain
    5. 5 Unidad de Metodología y Estadística, Osakidetza-Basque Health Service, Vitoria-Gasteiz, Spain
    6. 6 University of Vasque Country, Medicine Department, Pais Vasco, Spain
    1. Correspondence to Dr Joaquin Durán-Cantolla; joaquin.durancantolla{at}gmail.com

    Abstract

    Rationale Approximately 60% of the patients with obstructive sleep apnoea suffer from a positional effect, and approximately 25% of these patients present events only in the supine position.

    Objective To validate a new positional vibrating device and evaluate its efficacy in reducing the Apnoea–Hypopnoea Index and the total sleep time in the supine position without disturbing sleep.

    Methods A total of 128 patients were recruited for this multicentre, prospective, parallel, randomised controlled trial and were distributed in three arms (general recommendations, inactive and active device). Full overnight polysomnography was performed at baseline and at 12 weeks. Anthropometric variables and sleep and quality of life questionnaires were collected at 4, 8 and 12 weeks.

    Results The Apnoea-Hypopnoea Index decreased from 30.6 per hour to 20.4 per hour (p<0.001) in the active device (AD) group. In this group the reduction was 2.3-fold and 3.3-fold than the ones in the general recommendations (GR) and inactive device (ID) groups, respectively (p=0.014). Sleep time in supine position decreased 17.7%±26.3% in GR group (p<0.001), 13.0%±22.4% with ID group (p<0.001) and 21.0%±25.6% in the AD group (p<0.001). Furthermore, total sleep time increased significantly only in the AD group (22.1±57.5 min, p=0.016), with an increased percentage of time in the N3 (deep sleep) and N3+REM (rapid eye movement) stages, without sleep fragmentation.

    Conclusion The device was effective in reducing the Apnoea–Hypopnoea Index and time spent in the supine position also in improving sleep architecture. Therefore, the device could be a good option for the management of patients with positional obstructive sleep apnoea.

    Trial registration details The trial was registered at www.clinicaltrials.gov (NCT03336515).

    • equipment evaluations
    • sleep apnoea

    Data availability statement

    No data are available. No text will be published.

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    Data availability statement

    No data are available. No text will be published.

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    Footnotes

    • Collaborators The Spanish Sleep Network: Carlos Egea, Jose L Manjón, Cecilia Tourino.

    • Contributors LHA wrote the manuscript, collaborated in the recruitment of the patients, statistical treatment and participated and contributed in the review of the manuscript. JC-G contributed to statistical treatment data. SI contributed to the coordination and control of patients and devices. JU and JDC collaborated in data extraction from the devices. FB and RV contributed to the selection and recruitment of part of the sample. JD-C designed the study, reviewed the manuscript and contributed to all phases of the study. All authors contributed to commenting and editing of review drafts. All authors read and approved the final manuscript.

    • Funding The Sibelmed Company provided the devices to perform the study but did not take part in the study design, management of results or writing of the paper. 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).

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

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