None listed
Conditions
Brief summary
This is a pilot study looking at the treatment of obstructive sleep apnoea (OSA) in patients with atrial fibrillation (AF), using a mandibular advancement splint (MAS). MAS is an alternative treatment to CPAP (continuous positive airway pressure) therapy, which adheres to the top and bottom dental arches and brings the lower jaw forward, thus preventing upper airway collapse during sleep. There is evidence suggesting that treatment of OSA improves outcomes for patients suffering from AF. This may be particularly true for those patients who have had treatments for their AF such as Cardioversion or Pulmonary Vein isolation. There are no randomised control trials looking at MAS treatment for OSA in AF patients. This pilot study will collect data on patient acceptance, efficacy and compliance of MAS treatment in this patient group. Secondary outcomes include AF recurrence rates, changes in blood pressure, heart rate variability and quality of life questionnaires. Data from this important pilot study will inform a future randomised control trial.
Interventions
The exposure in this trial is a Mandibular Advancement Splint (MAS) for the treatment of Obstructive Sleep Apnoea.
MAS is an oral appliance device which adheres to the top and bottom dental arches and advances the mandible in relation to the maxilla.
The device will be manufactured for individual patients in the trial by a specialist dentist.
Study visits relating to the device are as follows:
Visit 1: Dental impressions taken
Visit 2 (4 weeks after visit 1): MAS splint fitting, titration, educa
The exposure in this trial is a Mandibular Advancement Splint (MAS) for the treatment of Obstructive Sleep Apnoea. MAS is an oral appliance device which adheres to the top and bottom dental arches and advances the mandible in relation to the maxilla. The device will be manufactured for individual patients in the trial by a specialist dentist. Study visits relating to the device are as follows: Visit 1: Dental impressions taken Visit 2 (4 weeks after visit 1): MAS splint fitting, titration, education. Ideally timed to occur prior to the patient's planned PVI, if relevant. Once Visit 2 has occurred, the treatment phase of the trial commences. Visit 3 (8 - 12 weeks after visit 1): MAS treatment review. Following the MAS treatment review, patients will wear the device over the trial period of 12 months. Regular trial assessments will take place at 3, 6 and 12 months following the start of the treatment phase. The efficacy of the device (improvement in the patient's sleep apnoea whilst wearing the device) will be assessed at 6 months with a repeat diagnostic sleep study. This will be compared to the patients' pre-treatment sleep study. Compliance will be assessed as average hours of nightly use as recorded by the inbuilt dentirac compliance recorder. Patient acceptance will be measured as the proportion of patients who continue to use MAS at the various timepoints (3, 6 and 12 months), as well as via MAS subjective assessment questionnaires.
Sponsors
Department of Respiratory and Sleep Medicine, Royal North Shore Hospital.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Completion of parent study with > or equal to 2 episodes of AF in the last 12 months. 2. Sleep Apnoea present: Apnoea Hypopnea index (AHI) > 10 3. Anatomically suitable for Mandibular Advancement Splint (MAS) eg sufficient number of native teeth as assessed by specialist dentist 4. Patient consent
Exclusion criteria
1. Anatomically unsuitable for MAS (eg insufficient native teeth). 2. Not physically able to complete the trial: eg geriatric issues including reduced mobility, frailty, frequent falls, need for carer 3. Life expectancy less than 12 months as judged by the study physician 4. Significant active comorbidities which may impair the patient's ability to complete the trial, including but not limited to severe cardiovascular disease, active malignancy, end-stage renal failure, hospital inpatient 5. Psychiatric/mental health conditions which may impair the ability to complete the trial
Outcome results
None listed