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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03232658
Registration number
NCT03232658
Ethics application status
Date submitted
25/07/2017
Date registered
28/07/2017
Titles & IDs
Public title
The Severity Of Individual Breathing Cessation Events In Diagnostics Of Obstructive Sleep Apnea
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Scientific title
The Severity Of Individual Breathing Cessation Events In Diagnostics Of Obstructive Sleep Apnea - Towards Enhanced And Individualized Estimation Of OSA Severity
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Secondary ID [1]
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0006-17-LOE
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea
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Condition category
Condition code
Respiratory
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Sleep apnoea
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Severity of individual obstruction events over time.
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Assessment method [1]
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We will explore how the duration of individual apnea and hypopnea events and duration, depth and area of individual desaturation events progress over time.
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Timepoint [1]
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From the beginning until December 2019
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Primary outcome [2]
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Optimization of OSA severity definition.
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Assessment method [2]
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Optimization of the diagnostic parameters of OSA which incorporates the severity of individual breathing cessation events.
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Timepoint [2]
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January 2018 until December 2020
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Primary outcome [3]
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Effect of severity of individual obstruction events on excessive daytime sleepiness.
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Assessment method [3]
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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))
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Timepoint [3]
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January 2018 until December 2019
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Primary outcome [4]
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Differences in severity of individual obstruction events between patients having severe OSA according to AHI.
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Assessment method [4]
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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.
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Timepoint [4]
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From the beginning until December 2018
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Primary outcome [5]
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The assessment of the therapeutic value of Positional Therapy for severe Non Positional Patients (NPP)
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Assessment method [5]
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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.
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Timepoint [5]
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From the beginning until December 2018
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Eligibility
Key inclusion criteria
* Good technical quality of polysomnographic (PSG) records
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Minimum age
16
Years
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Maximum age
95
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Bad technical quality of polysomnographic (PSG) records
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2020
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Actual
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Sample size
Target
10000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Sleep Disorders Centre, Department of Respiratory & Sleep Medicine, Princess Alexandra Hospital, Australia - Brisbane
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Recruitment postcode(s) [1]
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- Brisbane
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Recruitment outside Australia
Country [1]
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Finland
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State/province [1]
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Kuopio
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Country [2]
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Finland
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State/province [2]
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Seinäjoki
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Country [3]
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Israel
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State/province [3]
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Ra'anana
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Funding & Sponsors
Primary sponsor type
Other
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Name
Loewenstein Hospital
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Eastern Finland
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Seinajoki Central Hospital
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Kuopio University Hospital
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Princess Alexandra Hospital, Brisbane, Australia
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Address [4]
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Country [4]
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT03232658
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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Arie Oksenberg, PhD
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Address
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Loewenstein Hospital - Rehabilitation Center, Raanana, Israel
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Arie Oksenberg, PhD
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Address
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Country
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Phone
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+972 544755738
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
not relevant at this moment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03232658