None listed
Conditions
Brief summary
The purpose of this pre-post comparison study 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 in sleep clinic patients with OSA. Intermediary cardiovascular risk markers (peripheral and central blood pressure, arterial stiffness, endothelial function, autonomic function, and blood biomarkers) will be assessed at 3 and 6 months post OAT implementation. Efficacy of OAT in controlling OSA at the end of the study and adherence to OAT over the study period will be assessed via usage data downloaded from embedded adherence chip. Analysis will be performed to assess the influence of baseline cardiovascular risk status (hypertension, Framingham risk score) and treatment effectiveness (efficacy and usage) on changes in cardiovascular risk markers over the treatment period. The recruitment target (including allowance for drop outs) will be 105 participants. This is to ensure sufficient complete responders to OAT are recruited in the sample. There are known variations in OAT efficacy. Previous research suggests that <40% of OSA patients are complete responders to treatment, 30% have minimal clinical response and the remainder have some clinical benefit. We aim to have a minimum of 30 complete responders in the sample. Data from this observational study will be used to inform future trials of OSA therapy for cardiovascular disease prevention.
Interventions
Oral Appliance Therapy (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. All participants will receive OAT implemented by a dentist with experience in OAT according to standard clinical protocols and monitoring.
Participants will attend an initial dental visit to obtain impressions to manufactur
Oral Appliance Therapy (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. All participants will receive OAT implemented by a dentist with experience in OAT according to standard clinical protocols and monitoring. 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. Participants will have had a diagnostic sleep study performed for clinical purposes before entering the study. During the sleep study multiple physiological signals are monitored including respiration to assess for obstructive breathing events. At the end of the study (6 months), participants will have a repeat overnight sleep study (1 x 8 hours) in a clinical sleep laboratory, administered by the sleep laboratory staff and under their sleep specialist. The participant will use OAT for the duration of the study.
Sponsors
Northern Sydney Local Health District
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Obstructive Sleep Apnoea (with ODI(4%) > 10 events/hour) BMI < 35 kgm2
Exclusion criteria
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) 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 of lung disease (e.g. COPD) Inability to provide informed consent
Outcome results
None listed