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STUDY PROTOCOL article

Front. Sleep
Sec. Sleep and Breathing
Volume 3 - 2024 | doi: 10.3389/frsle.2024.1496923
This article is part of the Research Topic Novel technologies in the diagnosis and management of sleep-disordered breathing: Volume III View all 4 articles

Exploring SLEEPINESS through home monitoring with ultra longterm subcutaneous EEG and Ecological Momentary Assessment in sleepy treatment naïve obstructive sleep apnea patients starting CPAP treatment -a study protocol article

Provisionally accepted
Mathias Sarkez-Knudsen Mathias Sarkez-Knudsen 1*Martin Ballegaard Martin Ballegaard 2Henning Piilgaard Henning Piilgaard 2Esben Ahrens Esben Ahrens 3Martin Christian Hemmsen Martin Christian Hemmsen 3Tobias Søren Andersen Tobias Søren Andersen 4Jakob Bardram Jakob Bardram 5Preben Homøe Preben Homøe 1
  • 1 Zealand University Hospital, Department of Otorhinolaryngology, Køge, Denmark
  • 2 Zealand University Hospital, Department of Neurology, Roskilde, Denmark
  • 3 T&W Engineering A/S, Allerød, Denmark
  • 4 Department of Applied Mathematics and Computer Science, Technical University of Denmark, Kongens Lyngby, Denmark
  • 5 Department of Health Technology, Technical University of Denmark, Lyngby, Denmark

The final, formatted version of the article will be published soon.

    Introduction: Excessive Daytime Sleepiness (EDS) is a key symptom for patients with Obstructive Sleep Apnea (OSA). Despite important limitations in the longitudinal monitoring of EDS, the Epworth Sleepiness Scale (ESS), Maintenance of Wakefulness Test (MWT), and Multiple Sleep Latency Test (MSLT) are the best available objective tests to predict EDS. Limited information exists on the day-to-day fluctuations of sleepiness symptoms from the everyday life perspective of OSA patients. The most feared is sudden sleep episodes causing traffic accidents. The following study protocol investigates the novel possibilities of Ultra Long-Term EEG (ULT-EEG) home monitoring in sleepy OSA patients with a subcutaneous implant.We hypothesize that the high-frequency testing from ULT-EEG, in combination with Ecological Momentary Assessment (EMA), can provide the information to develop new electrophysiological monitoring of sleep propensity as an alternative to the well-established yet subjective Epworth Sleepiness Scale.Methods: This clinical exploratory and experimental study includes 15 treatment-naïve patients with severe OSA with a baseline ESS above 10. The subjects will be implanted with a two-channel subcutaneous EEG monitoring device upon inclusion and a confirmative Polysomnography (PSG) and Multiple Sleep Latency Test (MSLT). 24/7 subcutaneous EEG is recorded 6 weeks before CPAP treatment and 6 weeks during CPAP treatment. Daily assessments with the Karolinska Sleepiness Scale (KSS), Psychomotor Vigilance Task test (PVT), and a sleep/nap diary will be collected using EMA methods.Discussion: This study combines data collection from sleepy OSA patients' natural environments by ULT-EEG and EMA methods to obtain sleepiness metrics suitable for developing and preliminary validating the possibilities of ULT-EEG sleepiness monitoring. We aim to prove a new concept of monitoring sleepiness symptoms in OSA patients and gain new insights into CPAP-related sleepiness rehabilitation.Ethics and dissemination: All participants will provide written informed consent to participate in this study. Ethical approval from the Region Zealand Ethics Committee on 13/09/2021 (SJ939, EMN-2021-06803). The study will be conducted in accordance with local legislation and institutional requirements and comply with the Declaration of Helsinki and the General Data Protection Regulation (GDPR).

    Keywords: Ultra long-term EEG1, Obstructive Sleep Apnea2, sleepiness, Home-monitoring, average sleep propensity, biomarker

    Received: 15 Sep 2024; Accepted: 31 Dec 2024.

    Copyright: © 2024 Sarkez-Knudsen, Ballegaard, Piilgaard, Ahrens, Hemmsen, Andersen, Bardram and Homøe. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Mathias Sarkez-Knudsen, Zealand University Hospital, Department of Otorhinolaryngology, Køge, Denmark

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.