None listed
Conditions
Brief summary
All patients attending 2 dental practices for oral appliance therapy to treat obstructive sleep apnoea will be assessed for recruitment. Those who are able to sign informed consent will be enrolled. If a polysomnogram (PSG) has not been done, this will be done to confirm the apnoea hypopnoea index (AHI). Participants will be randomised to either usual care or usual care plus an apnealink study to evaluate treatment response. Should treatment response be inadequate as indicated by the ApneaLink in this group, further advancement of the mandible will be attempted. A repeat ApneaLink study will then be done and the process repeated. One month after titration is considered optimal, repeat PSG will be done. A repeat PSG will be done 1 month after optimal titration has been achieved in the control group. Secondary outcome measures of quality of life, symptoms and subjective sleepiness will be measured at baseline and at the time of the repeat PSG in both groups.
Interventions
An ApneaLink monitor will be used in the intervention group to measure baseline sleep apnoea severity and then again to measure the response to treatment. It is an overnight simplified sleep monitoring device. It will be used when the dentist feels that the oral appliance has been optimally titrated and then again if any further advancement is done. If the ApneaLink shows that the sleep apnoea is still inadequately treated, further advancement will be attempted and another ApneaLink study done.
An ApneaLink monitor will be used in the intervention group to measure baseline sleep apnoea severity and then again to measure the response to treatment. It is an overnight simplified sleep monitoring device. It will be used when the dentist feels that the oral appliance has been optimally titrated and then again if any further advancement is done. If the ApneaLink shows that the sleep apnoea is still inadequately treated, further advancement will be attempted and another ApneaLink study done. Thus the ApneaLink device will be used at least twice and it may be used several more times, depending on the adequacy of treatment and requirement for further advancement of the mandible with the oral appliance.
Sponsors
Institute for Breathing and Sleep
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Mild to moderate obstructive sleep apnoea (OSA) referred for oral appliance treatment
Exclusion criteria
Poor oral hygiene Inadequate dentition Unable to give informed consent
Outcome results
None listed