Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000402246p
Ethics application status
Not yet submitted
Date submitted
6/03/2018
Date registered
20/03/2018
Date last updated
20/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of Arterial Vasoreactivity and Arterial Stiffness Between Obesity Hypoventilation Syndrome and Obese Obstructive Sleep Apnoea
Scientific title
Comparison of Arterial Vasoreactivity and Arterial Stiffness Between Obesity Hypoventilation Syndrome and Obese Obstructive Sleep Apnoea
Secondary ID [1] 293734 0
None
Universal Trial Number (UTN)
U1111-1210-2962
Trial acronym
OHS-CVS Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity Hypoventilation Syndrome 306902 0
Obstructive Sleep Apnoea 306903 0
Cardiovascular Disease 306904 0
Condition category
Condition code
Respiratory 305994 305994 0 0
Sleep apnoea
Cardiovascular 305995 305995 0 0
Diseases of the vasculature and circulation including the lymphatic system
Diet and Nutrition 306089 306089 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Conditions observed:
Obesity hypoventilation syndrome (obese, daytime hypercapnia with paCO2 =/> 45mmHg)

Duration of observation:
At one point in time (at enrolment) i.e. cross-sectional study
Usually would be at diagnosis of condition
Intervention code [1] 300527 0
Diagnosis / Prognosis
Comparator / control treatment
Patients with obesity and obstructive sleep apnoea without daytime hypercapnia (paCO2 < 45mmHg)

Duration of observation:
At one point in time (at enrolment) i.e. cross-sectional study
Usually would be at diagnosis of condition
Control group
Active

Outcomes
Primary outcome [1] 305032 0
Change in cerebral oxygenation relative to change in expired CO2 partial tension between the two groups.
Cerebral oxygenation will be measured real time by near-infrared spectroscopy placed over the participants forehead during ventilatory manoeuvres which alters the expired CO2 partial tension.
Timepoint [1] 305032 0
At enrolment
Secondary outcome [1] 343938 0
Comparison of arterial stiffness between OHS and OSA groups:
Difference in augmentation index (corrected for heart rate) using pulse wave analysis
Timepoint [1] 343938 0
At enrolment
Secondary outcome [2] 343939 0
Comparison of arterial stiffness between OHS and OSA groups:
Difference in augmentation pressure (corrected for heart rate) using pulse wave analysis
Timepoint [2] 343939 0
At enrolment
Secondary outcome [3] 343944 0
Comparison of cardiovascular blood biomarkers between OHS and OSA groups:
N-terminal pro B-type natriuretic peptide by serum assay
Timepoint [3] 343944 0
At enrolment
Secondary outcome [4] 343945 0
Comparison of cardiovascular blood biomarkers between OHS and OSA groups:
high sensitivity Troponin T by serum assay
Timepoint [4] 343945 0
At enrolment
Secondary outcome [5] 343946 0
Comparison of cardiovascular blood biomarkers between OHS and OSA groups:
C-reactive protein by serum assay
Timepoint [5] 343946 0
At enrolment
Secondary outcome [6] 343947 0
Comparison of cardiovascular blood biomarkers between OHS and OSA groups:
Creatinine by serum assay
Timepoint [6] 343947 0
At enrolment
Secondary outcome [7] 343948 0
Comparison of cardiovascular blood biomarkers between OHS and OSA groups:
HbA1c by serum assay
Timepoint [7] 343948 0
At enrolment
Secondary outcome [8] 343949 0
Comparison of cardiovascular blood biomarkers between OHS and OSA groups:
Lipid profile by serum assay
Timepoint [8] 343949 0
At enrolment
Secondary outcome [9] 343953 0
Comparison of ECG abnormalities between OHS and OSA groups
Timepoint [9] 343953 0
At enrolment
Secondary outcome [10] 344084 0
Comparison of arterial stiffness between OHS and OSA groups:
Difference in pulse wave velocity
Timepoint [10] 344084 0
At enrolment

Eligibility
Key inclusion criteria
OHS group:
• BMI>30kg.m-2
• Daytime respiratory failure with a PaCO2>45mmHg (OHS group)
• pH is in the normal range at admission (7.35-7.45)
• Willingness to provide informed consent

OSA group:
• BMI>30kg.m-2
• AHI>30
• Willingness to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
OHS group:
• Presence of any other condition that may contribute to hypoventilation
• Uncontrolled medical or psychiatric conditions
• Recent myocardial infarction (6weeks)
• Any pre-existing CVA/TIA
• Any decompensated heart failure
• Long term positive airway pressure therapy prior to enrolment
• Women lactating or pregnant
• Not proficient in English
• Inability to provide informed consent

OSA group:
• Presence of hypercapnia (paCO2 > 45mmHg)
• Uncontrolled medical or psychiatric conditions
• Recent myocardial infarction (6weeks)
• Any pre-existing CVA/TIA
• Any decompensated heart failure
• Long term positive airway pressure therapy prior to enrolment
• Women lactating or pregnant
• Not proficient in English
• Inability to provide informed consent

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
As this is a pilot study and there is insufficient data to perform power analysis.
20 patients will be studied in total: 10 in the OHS group and 10 in the OSA group.
The baseline characteristics of both groups will be expressed as mean and SD or percentages with 95% CIs and compared using Student’s t-test and X2 analysis, respectively.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/04/2018
Actual
Date of last participant enrolment
Anticipated
26/02/2021
Actual
Date of last data collection
Anticipated
26/02/2021
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10257 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 21924 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 298348 0
Hospital
Name [1] 298348 0
Royal Prince Alfred Hospital
Country [1] 298348 0
Australia
Primary sponsor type
Individual
Name
Yizhong Zheng
Address
Department of Respiratory and Sleep Medicine
50 Missenden Rd
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 297468 0
Individual
Name [1] 297468 0
Dr Craig Phillips
Address [1] 297468 0
The Woolcock Institute of Medical Research
431 Glebe Point Road
Glebe NSW 2037 Sydney, Australia
Country [1] 297468 0
Australia
Other collaborator category [1] 279979 0
Individual
Name [1] 279979 0
Prof Ron Grunstein
Address [1] 279979 0
The Woolcock Institute of Medical Research
431 Glebe Point Road
Glebe NSW 2037 Sydney, Australia
Country [1] 279979 0
Australia
Other collaborator category [2] 279980 0
Individual
Name [2] 279980 0
Dr Brendon Yee
Address [2] 279980 0
Department of Respiratory and Sleep Medicine
50 Missenden Rd
Camperdown NSW 2050
Country [2] 279980 0
Australia
Other collaborator category [3] 279981 0
Individual
Name [3] 279981 0
Dr Keith Wong
Address [3] 279981 0
Department of Respiratory and Sleep Medicine
50 Missenden Rd
Camperdown NSW 2050
Country [3] 279981 0
Australia
Other collaborator category [4] 279982 0
Individual
Name [4] 279982 0
Dr David Wang
Address [4] 279982 0
Department of Respiratory and Sleep Medicine
50 Missenden Rd
Camperdown NSW 2050
Country [4] 279982 0
Australia
Other collaborator category [5] 279983 0
Individual
Name [5] 279983 0
Dr Amanda Piper
Address [5] 279983 0
Department of Respiratory and Sleep Medicine
50 Missenden Rd
Camperdown NSW 2050
Country [5] 279983 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 299341 0
Research Ethics and Governance Office of Sydney Local Health District
Ethics committee address [1] 299341 0
Ethics committee country [1] 299341 0
Australia
Date submitted for ethics approval [1] 299341 0
30/03/2018
Approval date [1] 299341 0
Ethics approval number [1] 299341 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2481 2481 0 0
/AnzctrAttachments/374265-OHS CVS protocol v4 March 6 2018.pdf (Protocol)
Attachments [2] 2482 2482 0 0
/AnzctrAttachments/374265-Project information CVS-OHS version 1 March 6 2018.pdf (Participant information/consent)
Attachments [3] 2483 2483 0 0
/AnzctrAttachments/374265-CONSENT OHS-CVS Project Participant Consent Form Nov 2017.pdf (Participant information/consent)

Contacts
Principal investigator
Name 80118 0
Dr Yizhong Zheng
Address 80118 0
Department of Respiratory and Sleep Medicine
50 Missenden Rd
Camperdown NSW 2050
Country 80118 0
Australia
Phone 80118 0
+61 2 91140497
Fax 80118 0
Email 80118 0
[email protected]
Contact person for public queries
Name 80119 0
Yizhong Zheng
Address 80119 0
Department of Respiratory and Sleep Medicine
50 Missenden Rd
Camperdown NSW 2050
Country 80119 0
Australia
Phone 80119 0
+61 2 91140497
Fax 80119 0
Email 80119 0
[email protected]
Contact person for scientific queries
Name 80120 0
Yizhong Zheng
Address 80120 0
Department of Respiratory and Sleep Medicine
50 Missenden Rd
Camperdown NSW 2050
Country 80120 0
Australia
Phone 80120 0
+61 2 91140497
Fax 80120 0
Email 80120 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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