Article Text

Download PDFPDF

Protocol of the SOMNIA project: an observational study to create a neurophysiological database for advanced clinical sleep monitoring
  1. Merel M van Gilst1,2,
  2. Johannes P van Dijk1,2,
  3. Roy Krijn1,2,
  4. Bertram Hoondert1,2,
  5. Pedro Fonseca1,3,
  6. Ruud J G van Sloun1,
  7. Bruno Arsenali1,
  8. Nele Vandenbussche1,2,
  9. Sigrid Pillen2,4,
  10. Henning Maass3,
  11. Leonie van den Heuvel3,
  12. Reinder Haakma3,
  13. Tim R Leufkens3,4,
  14. Coen Lauwerijssen5,
  15. Jan W M Bergmans1,3,
  16. Dirk Pevernagie2,
  17. Sebastiaan Overeem1,2
  1. 1Electrical Engineering, Technische Universiteit Eindhoven, Eindhoven, The Netherlands
  2. 2Center for Sleep Medicine, Kempenhaeghe Foundation, Heeze, Noord Brabant, The Netherlands
  3. 3Philips Research, Eindhoven, North Brabant, The Netherlands
  4. 4Industrial Design, Technische Universiteit Eindhoven, Eindhoven, The Netherlands
  5. 52M Engineering, Valkenswaard, The Netherlands
  1. Correspondence to Dr Merel M van Gilst; m.m.v.gilst{at}tue.nl

Abstract

Introduction Polysomnography (PSG) is the primary tool for sleep monitoring and the diagnosis of sleep disorders. Recent advances in signal analysis make it possible to reveal more information from this rich data source. Furthermore, many innovative sleep monitoring techniques are being developed that are less obtrusive, easier to use over long time periods and in the home situation. Here, we describe the methods of the Sleep and Obstructive Sleep Apnoea Monitoring with Non-Invasive Applications (SOMNIA) project, yielding a database combining clinical PSG with advanced unobtrusive sleep monitoring modalities in a large cohort of patients with various sleep disorders. The SOMNIA database will facilitate the validation and assessment of the diagnostic value of the new techniques, as well as the development of additional indices and biomarkers derived from new and/or traditional sleep monitoring methods.

Methods and analysis We aim to include at least 2100 subjects (both adults and children) with a variety of sleep disorders who undergo a PSG as part of standard clinical care in a dedicated sleep centre. Full-video PSG will be performed according to the standards of the American Academy of Sleep Medicine. Each recording will be supplemented with one or more new monitoring systems, including wrist-worn photoplethysmography and actigraphy, pressure sensing mattresses, multimicrophone recording of respiratory sounds including snoring, suprasternal pressure monitoring and multielectrode electromyography of the diaphragm.

Ethics and dissemination The study was reviewed by the medical ethical committee of the Maxima Medical Center (Eindhoven, the Netherlands, File no: N16.074). All subjects provide informed consent before participation.

The SOMNIA database is built to facilitate future research in sleep medicine. Data from the completed SOMNIA database will be made available for collaboration with researchers outside the institute.

  • sleep medicine
  • neurophysiology
  • polysomnography
  • database

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Footnotes

  • Contributors MMvG designed the study, arranged the data collection and drafted the manuscript. JPvD was involved in the study design and in writing the manuscript. RK designed the database. BH managed the data collection. PF, RJGvS, BA, NV, TL, CL, HM, RH, JWMB and LvdH assisted with implementing the experimental technologies. NV, SP and DP provided clinical expertise for the study design. SO conceived and supervised the study, was involved in the study design and in writing the manuscript. All authors read and approved the final manuscript.

  • Funding Parts of this study were supported by an Impulse grant (Advanced Sleep Monitoring, 2016), Open technology program (OSA+, STW/NWO, project no. 14619) and OPZuid (Bedsense, 2015).

  • Disclaimer These funding sources had no role in either study design or writing of the manuscript.

  • Competing interests PF, TL, HM, RH, JWMB and LvdH are employees of Philips Research. CL is employee of 2M Engineering.

  • Patient consent for publication Not required.

  • Ethics approval Maxima Medical Center (Eindhoven, the Netherlands, File no: N16.074).

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