Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000120673
Ethics application status
Approved
Date submitted
9/08/2005
Date registered
10/08/2005
Date last updated
7/07/2022
Date data sharing statement initially provided
7/07/2022
Date results information initially provided
7/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of efficacy and tolerability using two portable sleep apnoea monitoring devices: nocturnal oximetry versus nasal airflow in the triage diagnosis and screening of obstructive sleep apnoea.
Scientific title
A comparison of efficacy and tolerability using two portable sleep apnoea monitoring devices: nocturnal oximetry versus nasal airflow in the triage diagnosis and screening of obstructive sleep apnoea.
Secondary ID [1] 110 0
Nasal Flow Wizard and Nocturnal Masimo Oximetry in Obstructive Sleep Apnoea
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 208 0
Condition category
Condition code
Respiratory 232 232 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All subjects will be asked to complete screening questionnaires (the Epworth Sleepiness Scale, The Berlin Questionnaire, the Multivariate Apnea Index and a comfort and ease of use questionnaire) and these will take 3 minutes to complete. Anthropometric and demographic data will also be collected. Participants will be assigned to one of two groups. Group 1 will have their nasal flow measured with a nasal flow pressure transducer and their oxygen concentration measured with an oximeter for one night in parallel with in-laboratory full polysomnography (PSG) which involves monitoring sleep, ventilation and muscle activity. Group 2 subjects will have within an 8 week period (according to the patient circumstances and laboratory availability) one night of in-laboratory polysomnography (PSG) and 2 consecutive sets of three nights each at home using oximetry alone and nasal flow monitoring alone in random order without a resting period between each set. They will also be asked to complete the Karolinska Sleep diary for each night at home while using each device. This will take 2 minutes to complete.
Intervention code [1] 137 0
Diagnosis / Prognosis
Comparator / control treatment
For Group 1 In-laboratory full
polysomnography will be compared to single channel nasal flow and oximetry and for group 2 in-laboratory full PSG will be compared to 2 sets of
three nights each at home on oximetry alone and nasal flow alone in
random order. Subjects will also complete the Karolinska Sleep diary for
each night at home while using each device.
Control group
Active

Outcomes
Primary outcome [1] 279 0
To assess and compare the diagnostic accuracy of nasal flow and oximetry in the laboratory and at home for a single and
three nights of use with respect to in-laboratory full polysomnography for obstructive sleep apnea using a number of statistical methods including receiver operator characteristic curves and likelihood ratios.
Timepoint [1] 279 0
At the completion of the trial when adequate data has been obtained from the number of subjects required. All data points should be collected within an 8 week period from the initiation of the trial for each subject. Data points will be measured during nasal flow and oximetry in the laboratory and at home for a single and three nights of use, and during in-laboratory full polysomnography
Secondary outcome [1] 623 0
To compare the accuracy of single versus
multiple nights of use at home on each device with respect to in-laboratory full polysomnography for obstructive sleep apnea using a number of statistical methods including receiver operator characteristic curves and likelihood ratios.
Timepoint [1] 623 0
At the completion of the trial when adequate data has been obtained from the number of subjects required. All data points should be collected within an 8 week period from the initiation of the trial for each subject. Data points will be measured during nasal flow and oximetry in the laboratory and at home for a single and three nights of use, and during in-laboratory full polysomnography
Secondary outcome [2] 624 0
To develop and validate a diagnostic algorithm based on either nasal flow or oximetry and anthropometric and questionnaire data for obstructive sleep apnoea
Timepoint [2] 624 0
At the completion of the trial when adequate data has been obtained from the number of subjects required. All data points should be collected within an 8 week period from the initiation of the trial for each subject. Data points will be measured during nasal flow and oximetry in the laboratory and at home for a single and three nights of use, and during in-laboratory full polysomnography
Secondary outcome [3] 8188 0
To assess data quality using statistical methods and the comfort and
ease of use of the two devices at home using a Likert scale questionnaire
Timepoint [3] 8188 0
At the completion of the trial when adequate data has been obtained from the number of subjects required. All data points should be collected within an 8 week period from the initiation of the trial for each subject. Data points will be measured during nasal flow and oximetry in the laboratory and at home for a single and three nights of use, and during in-laboratory full polysomnography

Eligibility
Key inclusion criteria
1.Subjects presenting to the sleep laboratory for assessment of obstructive sleep apnea
2.Age = 21
3.Able to give consent
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Clinically significant co morbidity,
including any unstable cardiovascular, gastrointestinal, metabolic,
pulmonary (e.g., asthma, chronic obstructive pulmonary disease, etc), renal, neurological, hepatic,
hematologic, immunologic, endocrine, psychiatric illness and/or
neoplastic disease.
2.Patients unable to apply the monitoring devices (e.g. severe hand
arthritis, neuromuscular disease).
3.Shift workers
4.Known underlying sleep disorder

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/07/2005
Actual
3/07/2006
Date of last participant enrolment
Anticipated
Actual
1/11/2007
Date of last data collection
Anticipated
Actual
7/01/2008
Sample size
Target
305
Accrual to date
Final
193
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 354 0
2050

Funding & Sponsors
Funding source category [1] 293 0
Other
Name [1] 293 0
Woolcock Institute of Medical Research
Country [1] 293 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
PO Box M77 Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 224 0
Government body
Name [1] 224 0
NHMRC CCRE for Respiratory and Sleep Medicine
Address [1] 224 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 224 0
Australia
Secondary sponsor category [2] 225 0
Hospital
Name [2] 225 0
Royal Prince Alfred Hospital
Address [2] 225 0
RPA Hospital
Missenden Road
Camperdown NSW 2050
Country [2] 225 0
Australia
Secondary sponsor category [3] 226 0
University
Name [3] 226 0
University of Sydney
Address [3] 226 0
University of Sydney
NSW 2006
Country [3] 226 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1157 0
Sydney South West Area Health Service Human Research Ethics Committee
Ethics committee address [1] 1157 0
Research Development Office
Level 3, Building 92
Royal Prince Alfred Hospital
Camperdown NSW 2050
Ethics committee country [1] 1157 0
Australia
Date submitted for ethics approval [1] 1157 0
Approval date [1] 1157 0
17/06/2005
Ethics approval number [1] 1157 0
X05-0105

Summary
Brief summary
Obstructive Sleep Apnea (OSA) is a common disorder. It is linked to heart disease, stroke high blood pressure and poor cognition as well as motor vehicle and work accidents. However till now the diagnostic gold standard is in hospital overnight sleep study. This is expensive time consuming and has limited availability. Studies investigating the use of simple single channel monitors for OSA detection at home have predominantly involved device that measure oxygen in the blood (oximeters) with limited data available for devices that measure breathing (nasal flow). Our aim was to assess and compare the validity of nasal flow and oximetry recordings using separate single channel monitors in the laboratory on the same night as the sleep study and at home for a single and three nights each with respect to the laboratory sleep study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35840 0
Dr Lydia Rofail
Address 35840 0
Woolcock Institute of Medical Research 431 Glebe Point Road GLEBE NSW 2037
Country 35840 0
Australia
Phone 35840 0
+61 2 91140497
Fax 35840 0
Email 35840 0
[email protected]
Contact person for public queries
Name 9326 0
Ms Sarah Newton-John
Address 9326 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9326 0
Australia
Phone 9326 0
+61 2 9114 0436
Fax 9326 0
+61 2 9114 0011
Email 9326 0
[email protected]
Contact person for scientific queries
Name 254 0
Dr Lydia Rofail
Address 254 0
Woolcock Institute of Medical Research
431 Glebe Point Road
GLEBE NSW 2037
Country 254 0
Australia
Phone 254 0
+61 2 91140497
Fax 254 0
+61 2 91140014
Email 254 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant underlying published results only.
When will data be available (start and end dates)?
Data will be made available upon request, after publication, with no end date determined.
Available to whom?
Data will be made available upon request, after publication and will be determined upon negotiation with researchers who provided a methodologically sound proposal.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Secure data transfer and signed data access agreement. Contact: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Published: 01 August 2010 https://doi.org/10.1093/... [More Details]

Documents added automatically
No additional documents have been identified.