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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
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.
Timepoint [1] 0 0
From the beginning until December 2019
Primary outcome [2] 0 0
Optimization of OSA severity definition.
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.
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.
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)
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Bad technical quality of polysomnographic (PSG) records

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2020
Actual
Sample size
Target
10000
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
not relevant at this moment


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