The Severity Of Individual Breathing Cessation Events In Diagnostics Of Obstructive Sleep Apnea
1 other identifier
observational
10,000
3 countries
4
Brief Summary
Obstructive sleep apnea (OSA) is a common nocturnal breathing disorder characterized by complete (apnea) and partial (hypopnea) breathing cessations during sleep. Currently, clinical diagnosis of OSA is based on the clinical symptoms, especially excessive daytime sleepiness, and apnea-hypopnea index (AHI) providing a limited overview of the breathing cessation event frequency during the night. Longer obstruction events and deeper desaturations have been suggested to be more harmful than shorter and shallower events and these individual characteristics are completely neglected by conventional and currently used AHI. The investigators have previously introduced novel diagnostic parameters incorporating the number, duration and morphology of individual obstruction events and shown that they improve the severity estimation of OSA compared to traditional measures. Even though, the novel diagnostic parameters have so far tackled some of shortcomings of AHI, they need to be refined to further increase the accuracy of the OSA severity estimation. It has been shown that age, body mass index (BMI) and sleeping position are strongly related to the severity OSA. However, it is not thoroughly studied whether the severity of individual obstruction events progress over time (the aging process) and which factors affect to this progression. It is known that OSA patients with similar AHI values, durations of individual breathing cessation events can differ significantly. Longer and deeper events are connected to increased mortality rate in patients with moderate or severe OSA and thus, could be considered to be more detrimental than shorter and shallower ones. However, it has not been thoroughly investigated whether in severe OSA patients with identical AHI values, sleep efficiency or hypertension is related to the severity of individual breathing cessation events. The investigators planned to explore, whether the individual breathing cessation event severity progress over time and how different confounding factors affect this progression. Furthermore, the correlation of EDS with the individual breathing cessation event severity, sleep structure, and frequency and occurrence of cortical arousals will be investigated. Also, the investigators will explore whether the percentage time of disturbed breathing from total sleep time is related to sleep efficiency or hypertension in severe OSA patients having similar AHI. Moreover, Positional therapy (PT) i.e., the avoidance of the supine posture during sleep is the treatment of choice for Positional Patients (PP) having most of their breathing abnormalities while sleeping supine. Since it is known that apneas/hypopneas are more severe while sleeping supine, this time the investigators will assess the therapeutic value of PT for severe Non Positional patients (NPP).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2018
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2017
CompletedFirst Posted
Study publicly available on registry
July 28, 2017
CompletedStudy Start
First participant enrolled
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedFebruary 28, 2019
February 1, 2019
2.8 years
July 25, 2017
February 26, 2019
Conditions
Outcome Measures
Primary Outcomes (5)
Severity of individual obstruction events over time.
We will explore how the duration of individual apnea and hypopnea events and duration, depth and area of individual desaturation events progress over time.
From the beginning until December 2019
Optimization of OSA severity definition.
Optimization of the diagnostic parameters of OSA which incorporates the severity of individual breathing cessation events.
January 2018 until December 2020
Effect of severity of individual obstruction events on excessive daytime sleepiness.
We will investigate the correlation between the severity of individual breathing cessation events and excessive daytime sleepiness measured with objective means (i.e. Multiple Sleep Latency Test (MSLT) and Maintenance of Wakefulness Test (MWT))
January 2018 until December 2019
Differences in severity of individual obstruction events between patients having severe OSA according to AHI.
Severe OSA patients will be matched by AHI and the percentage time of disturbed breathing from total sleep time will be compared between these patients.
From the beginning until December 2018
The assessment of the therapeutic value of Positional Therapy for severe Non Positional Patients (NPP)
Positional therapy is an optimal therapeutic mode for PP but since the severity of apneas/hypopneas is worst in the supine than in the lateral posture, NPP could also obtain some benefits of this therapy we will assess the value of this possible benefit.
From the beginning until December 2018
Eligibility Criteria
In-laboratory PSG recordings (n=7540) including EEG conducted and analysed at the Sleep Disorders Unit, Loewenstein Hospital - Rehabilitation Center for the patients with clinical suspicion of OSA will be studied.
You may qualify if:
- Good technical quality of polysomnographic (PSG) records
You may not qualify if:
- Bad technical quality of polysomnographic (PSG) records
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Loewenstein Hospitallead
- University of Eastern Finlandcollaborator
- Seinajoki Central Hospitalcollaborator
- Kuopio University Hospitalcollaborator
- Princess Alexandra Hospital, Brisbane, Australiacollaborator
Study Sites (4)
Sleep Disorders Centre, Department of Respiratory & Sleep Medicine, Princess Alexandra Hospital, Australia
Brisbane, Australia
Department of Applied Physics, University of Eastern Finland
Kuopio, Finland
Department of Clinical Neurophysiology, Seinäjoki Central Hospital,
Seinäjoki, Finland
Sleep Disorders Unit - Loewenstein Hospital
Raanana, 43100, Israel
Related Publications (1)
Oksenberg A, Gadoth N, Toyras J, Leppanen T. Prevalence and characteristics of positional obstructive sleep apnea (POSA) in patients with severe OSA. Sleep Breath. 2020 Jun;24(2):551-559. doi: 10.1007/s11325-019-01897-1. Epub 2019 Jul 20.
PMID: 31325020DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arie Oksenberg, PhD
Loewenstein Hospital - Rehabilitation Center, Raanana, Israel
- PRINCIPAL INVESTIGATOR
Juha Töyräs, PhD
University of Eastern Finland
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Arie Oksenberg, PhD- Director Sleep Disorders Unit
Study Record Dates
First Submitted
July 25, 2017
First Posted
July 28, 2017
Study Start
March 1, 2018
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
February 28, 2019
Record last verified: 2019-02