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The Severity Of Individual Breathing Cessation Events In Diagnostics Of Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT03232658
Recruitment Status : Recruiting
First Posted : July 28, 2017
Last Update Posted : February 28, 2019
Sponsor:
Collaborators:
University of Eastern Finland
Seinajoki Central Hospital
Kuopio University Hospital
Princess Alexandra Hospital, Brisbane, Australia
Information provided by (Responsible Party):
Arie Oksenberg, Loewenstein Hospital

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).


Condition or disease
Obstructive Sleep Apnea

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Severity Of Individual Breathing Cessation Events In Diagnostics Of Obstructive Sleep Apnea - Towards Enhanced And Individualized Estimation Of OSA Severity
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea




Primary Outcome Measures :
  1. Severity of individual obstruction events over time. [ Time Frame: From the beginning until December 2019 ]
    We will explore how the duration of individual apnea and hypopnea events and duration, depth and area of individual desaturation events progress over time.

  2. Optimization of OSA severity definition. [ Time Frame: January 2018 until December 2020 ]
    Optimization of the diagnostic parameters of OSA which incorporates the severity of individual breathing cessation events.

  3. Effect of severity of individual obstruction events on excessive daytime sleepiness. [ Time Frame: January 2018 until December 2019 ]
    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))

  4. Differences in severity of individual obstruction events between patients having severe OSA according to AHI. [ Time Frame: From the beginning until December 2018 ]
    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.

  5. The assessment of the therapeutic value of Positional Therapy for severe Non Positional Patients (NPP) [ Time Frame: From the beginning until December 2018 ]
    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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Ages Eligible for Study:   16 Years to 95 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Good technical quality of polysomnographic (PSG) records

Exclusion Criteria:

  • Bad technical quality of polysomnographic (PSG) records

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03232658


Contacts
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Contact: Arie Oksenberg, PhD +972 544755738 arieo@clalit.org.il
Contact: Juha Töyräs, Professor +358 40 3552026 juha.toyras@uef.fi

Locations
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Australia
Sleep Disorders Centre, Department of Respiratory & Sleep Medicine, Princess Alexandra Hospital, Australia Enrolling by invitation
Brisbane, Australia
Finland
Department of Applied Physics, University of Eastern Finland Enrolling by invitation
Kuopio, Finland
Department of Clinical Neurophysiology, Seinäjoki Central Hospital, Enrolling by invitation
Seinäjoki, Finland
Israel
Sleep Disorders Unit - Loewenstein Hospital Recruiting
Ra'anana, Israel, 43100
Contact: Arie Oksenberg, PhD    +972544755738    arieo@clalit.org.il   
Contact: Natan Gadoth, MD    +972546229346    gadoth@post.tau.ac.il   
Sponsors and Collaborators
Loewenstein Hospital
University of Eastern Finland
Seinajoki Central Hospital
Kuopio University Hospital
Princess Alexandra Hospital, Brisbane, Australia
Investigators
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Principal Investigator: Arie Oksenberg, PhD Loewenstein Hospital - Rehabilitation Center, Raanana, Israel
Principal Investigator: Juha Töyräs, PhD University of Eastern Finland

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Arie Oksenberg, Arie Oksenberg, PhD- Director Sleep Disorders Unit, Loewenstein Hospital
ClinicalTrials.gov Identifier: NCT03232658     History of Changes
Other Study ID Numbers: 0006-17-LOE
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: not relevant at this moment

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases