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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03232658




Registration number
NCT03232658
Ethics application status
Date submitted
25/07/2017
Date registered
28/07/2017
Date last updated
28/02/2019

Titles & IDs
Public title
The Severity Of Individual Breathing Cessation Events In Diagnostics Of Obstructive Sleep Apnea
Scientific title
The Severity Of Individual Breathing Cessation Events In Diagnostics Of Obstructive Sleep Apnea - Towards Enhanced And Individualized Estimation Of OSA Severity
Secondary ID [1] 0 0
0006-17-LOE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
From the beginning until December 2019
Primary outcome [2] 0 0
Optimization of OSA severity definition. - Optimization of the diagnostic parameters of OSA which incorporates the severity of individual breathing cessation events.
Timepoint [2] 0 0
January 2018 until December 2020
Primary outcome [3] 0 0
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))
Timepoint [3] 0 0
January 2018 until December 2019
Primary outcome [4] 0 0
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.
Timepoint [4] 0 0
From the beginning until December 2018
Primary outcome [5] 0 0
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.
Timepoint [5] 0 0
From the beginning until December 2018

Eligibility
Key inclusion criteria
- Good technical quality of polysomnographic (PSG) records
Minimum age
16 Years
Maximum age
95 Years
Gender
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Bad technical quality of polysomnographic (PSG) records

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sleep Disorders Centre, Department of Respiratory & Sleep Medicine, Princess Alexandra Hospital, Australia - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment outside Australia
Country [1] 0 0
Finland
State/province [1] 0 0
Kuopio
Country [2] 0 0
Finland
State/province [2] 0 0
Seinäjoki
Country [3] 0 0
Israel
State/province [3] 0 0
Ra'anana

Funding & Sponsors
Primary sponsor type
Other
Name
Loewenstein Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Eastern Finland
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Seinajoki Central Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Kuopio University Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Princess Alexandra Hospital, Brisbane, Australia
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/show/NCT03232658
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Arie Oksenberg, PhD
Address 0 0
Loewenstein Hospital - Rehabilitation Center, Raanana, Israel
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Arie Oksenberg, PhD
Address 0 0
Country 0 0
Phone 0 0
+972 544755738
Fax 0 0
Email 0 0
arieo@clalit.org.il
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03232658