Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000419268
Ethics application status
Approved
Date submitted
4/05/2009
Date registered
9/06/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of continuous positive airways pressure (CPAP) therapy on cardiovascular risk factors in type 2 diabetic patients with newly-diagnosed sleep apnoea
Scientific title
Effects of continuous positive airways pressure (CPAP) therapy on cardiovascular risk factors in type 2 diabetic patients with newly-diagnosed sleep apnoea
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 4714 0
Sleep apnoea 4715 0
Condition category
Condition code
Metabolic and Endocrine 5036 5036 0 0
Diabetes
Respiratory 237263 237263 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Continuous positive airways pressure (CPAP) administered by an air pump and mask every night during sleep over a 3 month period. Nocturnal CPAP will be commenced immediately sleep apnoea is diagnosed. Patients will also be given lifestyle advice including on weight loss and sleeping position prior to CPAP being started at a one-on-one physician appointment with further follow-up (at least fortnightly) with sleep clinic nursing staff.
Intervention code [1] 4481 0
Treatment: Devices
Comparator / control treatment
Continuous positive airways pressure (CPAP) given 3 months after sleep apnoea is diagnosed and lifestyle interventions have been recommended (as per Description of intervention above). The only difference between the intervention and control will be the timing of commencement of CPAP (immediate vs 3 months)
Control group
Active

Outcomes
Primary outcome [1] 5875 0
Change in fasting plasma glucose measured by enzymatic laboratory assay in the early vs delayed intervention groups
Timepoint [1] 5875 0
Baseline to 4 weeks, baseline referring to the time CPAP is started.
Primary outcome [2] 238088 0
Change in glycosylated haemoglobin (HbA1c) measured by high performance liquid chromatography laboratory assay in the early vs delayed intervention groups
Timepoint [2] 238088 0
Baseline to 4 weeks and 3 months, baseline referring to the time CPAP is started.
Primary outcome [3] 238089 0
Change in fasting serum lipids measured by automated biochemical laboratory assay in the early vs delayed intervention groups
Timepoint [3] 238089 0
Baseline to 4 weeks and 3 months, baseline referring to the time CPAP is started.
Primary outcome [4] 238090 0
Change in blood pressure measured by automated sphygmomanometer in the early vs delayed intervention groups
Timepoint [4] 238090 0
Baseline to 4 weeks and 3 months, baseline referring to the time CPAP is started.
Secondary outcome [1] 241905 0
Change in quality of life scores (SF-12; Audit of Diabetes Dependent QoL (ADDQoL) for diabetic patients; Patient Health Questionnaire-9 for depressive symptoms; Barthel index and Instrumental Activities of Daily Living Scale)
Timepoint [1] 241905 0
Baseline to 4 weeks and 3 months, baseline referring to the time CPAP is started.
Secondary outcome [2] 242287 0
Self-reported frequency/duration of physical activity during the previous week using the Active Australia Survey questionnaire
Timepoint [2] 242287 0
Baseline to 4 weeks and 3 months, baseline referring to the time CPAP is started.
Secondary outcome [3] 242288 0
Serum testosterone (in males) measured by biochemical laboratory assay (liquid chromatography/mass spectrometry)
Timepoint [3] 242288 0
Baseline to 4 weeks and 3 months, baseline referring to the time CPAP is started.

Eligibility
Key inclusion criteria
Patients with type 2 diabetes aged at least 18 years of either gender who screen positive for sleep apnoea by ApneaLink overnight study and Berlin questionnaire
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Already on CPAP or previous trial of CPAP therapy unsuccessful or not tolerated

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
If polysomnography is positive, patients will be randomised by computer-generated randomisation in a pre-sealed envelope to immediate or delayed CPAP intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated binary randomisation sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4891 0
Self funded/Unfunded
Name [1] 4891 0
Country [1] 4891 0
Primary sponsor type
University
Name
School of Medicine and Pharmacology, University of Western Australia
Address
Fremantle Hospital
PO Box 480
Fremantle
Western Australia 6959
Country
Australia
Secondary sponsor category [1] 4425 0
None
Name [1] 4425 0
Address [1] 4425 0
Country [1] 4425 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6956 0
South Metropolitan Area Health Service Human Research Ethics Committee
Ethics committee address [1] 6956 0
Fremantle Hospital
PO Box 480
Fremantle
Western Australia 6959
Ethics committee country [1] 6956 0
Australia
Date submitted for ethics approval [1] 6956 0
Approval date [1] 6956 0
12/01/2009
Ethics approval number [1] 6956 0

Summary
Brief summary
Sleep apnoea (a sleep disorder characterized by pauses in breathing during sleep) is associated with high blood pressure, high blood glucose and overweight in the general population, and a consequent increase in cardiovascular disease and death as a result. There are, however, few data relating to these associations in the special case of diabetes. It is also likely the treating sleep apnoea with continuous positive airways pressure (CPAP) will be especially beneficial to diabetic patients. In a sample of diabetic patients with confirmed sleep apnoea, we will see whether CPAP therapy improves blood glucose levels, blood pressure and other risk factors for vascular disease, as well as looking at its effects on quality of life and sexual function. The results should provide evidence of the value of screening for, and treatment of, sleep apnoea in people with diabetes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29565 0
Address 29565 0
Country 29565 0
Phone 29565 0
Fax 29565 0
Email 29565 0
Contact person for public queries
Name 12812 0
Tim Davis
Address 12812 0
Fremantle Hospital
PO Box 480
Fremantle
Western Australia 6959
Country 12812 0
Australia
Phone 12812 0
+618 9431 3229
Fax 12812 0
Email 12812 0
[email protected]
Contact person for scientific queries
Name 3740 0
Tim Davis
Address 3740 0
Fremantle Hospital
PO Box 480
Fremantle
Western Australia 6959
Country 3740 0
Australia
Phone 3740 0
+618 9431 3229
Fax 3740 0
Email 3740 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.