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Trial registered on ANZCTR


Registration number
ACTRN12620000014954
Ethics application status
Approved
Date submitted
11/12/2019
Date registered
14/01/2020
Date last updated
14/01/2020
Date data sharing statement initially provided
14/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Oral Appliance Therapy (OAT) for Obstructive Sleep Apnoea (OSA) on markers of cardiovascular risk
Scientific title
A pilot sham-controlled trial of effect of Oral Appliance Therapy (OAT) for Obstructive Sleep Apnoea (OSA) on intermediary markers of cardiovascular risk
Secondary ID [1] 300058 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 315584 0
Cardiovascular Disease 315645 0
Condition category
Condition code
Respiratory 313870 313870 0 0
Sleep apnoea
Cardiovascular 314066 314066 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral Appliance Therapy (OAT) for Obstructive Sleep Apnoea

OAT is a recommended therapy for OSA. The therapy entails wearing a customised dental device during sleep. The device is digitally milled from dental impressions obtained by a dentist, and hence each device is customised to an individual's dentition.
In this trial OAT will be implemented by a dentist with previous experience in OAT. OAT will be monitored by the treating dentist throughout the trial.
Participants will attend an initial dental visit to obtain impressions to manufacture the device (~1 hour).
The device will be fitted by the dentist at a second visit (~40 minutes).
Participants will be instructed to wear the device whenever they sleep for the duration of the trial (6 months).
Participants will have follow-up dental visits at mid-point (3 months) and end of the trial (6 months, ~30 minutes per visit). Participants will have opportunity for additional dental visits on an ad hoc basis if there are any issues which require assessment by the dentist, such as issues with device fit.
All devices are fitted with an objective compliance monitor, a small temperature-sensing chip which is embedded within the appliance material. Compliance data will be downloaded from the chip using a reading station at study visits.
Intervention code [1] 316332 0
Treatment: Devices
Comparator / control treatment
Sham oral appliance (without therapeutic mechanism of action).
Control group
Placebo

Outcomes
Primary outcome [1] 322263 0
change in 24 hour blood pressure (peripheral and central measured by Oscar 2 ambulatory blood pressure monitor with SphygmoCor)
Timepoint [1] 322263 0
3 and 6 (primary endpoint) months post intervention commencement
Primary outcome [2] 322266 0
change in endothelial function (flow mediated dilation of brachial artery by ultrasound)
Timepoint [2] 322266 0
3 and 6 (primary endpoint) months post intervention commencement
Primary outcome [3] 322267 0
change in arterial stiffness (pulse wave velocity)
Timepoint [3] 322267 0
3 and 6 (primary endpoint) months post intervention commencement
Secondary outcome [1] 377906 0
Adherence to therapy (data download from sensor chip in appliance)
Timepoint [1] 377906 0
Daily usage over 6 month intervention period
Secondary outcome [2] 377907 0
OAT efficacy, change in sleep apnea events as assessed by overnight polysomnography
Timepoint [2] 377907 0
6 months post intervention commencement
Secondary outcome [3] 377908 0
Change in subjective daytime sleepiness (Epworth Sleepiness Score)
Timepoint [3] 377908 0
3 and 6 months post intervention commencement
Secondary outcome [4] 377909 0
Change in health related quality of life (SF-36 questionnaire)
Timepoint [4] 377909 0
3 and 6 months post intervention commencement
Secondary outcome [5] 377910 0
Change in disease-related quality of life (Functional Outcomes of Sleep Questionnaire)
Timepoint [5] 377910 0
3 and 6 months post intervention commencement
Secondary outcome [6] 377913 0
change in autonomic function (heart rate variability, ECG)
Timepoint [6] 377913 0
3 and 6 months post intervention commencement
Secondary outcome [7] 377914 0
change in carotid intima media thickness (ultrasound)
Timepoint [7] 377914 0
3 and 6 months post intervention commencement
Secondary outcome [8] 378141 0
change in autonomic function (blood pressure variability, Human Non-Invasive Blood Pressure System, NIBP )
Timepoint [8] 378141 0
3 and 6 months post intervention commencement
Secondary outcome [9] 378144 0
change in autonomic function (baroreceptor reflex function, Human Non-Invasive Blood Pressure System, NIBP)
Timepoint [9] 378144 0
3 and 6 months post intervention commencement
Secondary outcome [10] 378610 0
OAT efficacy, change in oxygen saturation assessed by home oximtery
Timepoint [10] 378610 0
6 months post intervention commencement

Eligibility
Key inclusion criteria
Obstructive Sleep Apnoea (with ODI(4%) > 15 events/hour)
Framingham risk score >15%
BMI < 35 kgm2
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous use of OAT for OSA
Use of any OSA therapy in the prior 3 months
Contra-indications to OAT (as determined by dentist (e.g. periodontal disease, insufficient number of teeth to retain the device)
Need for immediate OSA therapy as assessed by a sleep physician (e.g. commercial drivers)
Women who are lactating or pregnant
Established cardio- or cerebro-vascular disease (e.g. stroke, coronary heart disease, heart failure, cardiomyopathy, congenital heart disease)
Central Sleep Apnoea (>10% central events)
Co-existing sleep disorder or lung disease (e.g. COPD)
Inability to provide informed consent

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)
centralised randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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)
NSW
Recruitment hospital [1] 15458 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 15459 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 28811 0
2065 - St Leonards
Recruitment postcode(s) [2] 28812 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 304510 0
Charities/Societies/Foundations
Name [1] 304510 0
Rebecca L Cooper Medical Foundation
Address [1] 304510 0
26/100 New South Head Rd, Sydney NSW 2027
Country [1] 304510 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Local Health District
Address
Douglas Building, Level 5 Reserve Rd, St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 304778 0
None
Name [1] 304778 0
Address [1] 304778 0
Country [1] 304778 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304940 0
Northern Sydney Local Health District
Ethics committee address [1] 304940 0
Douglas Building, Level 5 Reserve Rd, St Leonards NSW 2065
Ethics committee country [1] 304940 0
Australia
Date submitted for ethics approval [1] 304940 0
Approval date [1] 304940 0
04/09/2019
Ethics approval number [1] 304940 0

Summary
Brief summary
The purpose of this pilot trial is to provide preliminary evidence for any effect of Oral Appliance Therapy (OAT) for Obstructive Sleep Apnoea (OSA) on a range of intermediary cardiovascular risk markers (vs. control group) in sleep clinic patients with OSA identified to be at high cardiovascular risk (Framingham risk assessment) but without established cardiovascular disease.
Intermediary cardiovascular risk markers (peripheral and central blood pressure, arterial stiffness, endothelial function, autonomic function, carotid intima-media thickness, and blood biomarkers) will be assessed at 3 and 6 months post OAT implementation. Efficacy of OAT in controlling OSA at the end of study and adherence to OAT over the study period will also be assessed.
The recruitment target is 105 participants, aiming for 35 in the control arm and 70 in the OAT arm. The OAT arm recruitment has been inflated due to known variations in OAT efficacy to aim to achieve 35 participants who show high efficacy to OAT.
Data from this pilot trial will be used to inform future trials of OAT for cardiovascular disease prevention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98706 0
Dr Kate Sutherland
Address 98706 0
Dept of Respiratory and Sleep Medicine
Royal North Shore Hospital
Pacific Highway
St Leonards NSW 2065
Country 98706 0
Australia
Phone 98706 0
+61 02 9463 2924
Fax 98706 0
Email 98706 0
kate.sutherland@sydney.edu.au
Contact person for public queries
Name 98707 0
Dr Kate Sutherland
Address 98707 0
Dept of Respiratory and Sleep Medicine
Royal North Shore Hospital
Pacific Highway
St Leonards NSW 2065
Country 98707 0
Australia
Phone 98707 0
+61 02 9463 2924
Fax 98707 0
Email 98707 0
kate.sutherland@sydney.edu.au
Contact person for scientific queries
Name 98708 0
Dr Kate Sutherland
Address 98708 0
Dept of Respiratory and Sleep Medicine
Royal North Shore Hospital
Pacific Highway
St Leonards NSW 2065
Country 98708 0
Australia
Phone 98708 0
+61 02 9463 2924
Fax 98708 0
Email 98708 0
kate.sutherland@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results