None listed
Conditions
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.
Interventions
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 de
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.
Sponsors
Northern Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Obstructive Sleep Apnoea (with ODI(4%) > 15 events/hour) Framingham risk score >15% BMI < 35 kgm2
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
Outcome results
None listed