None listed
Conditions
Brief summary
In this study, we propose to study the effects of 2 types of treatment for positional sleep apnoea. Positional sleep apnoea is when you have more sleep apnoea, when you sleep on your back. The first treatment is called MAS or a mouthguard which is like a denture worn during sleep to improve sleep apnoea. the second treatment is called night shift, this is a vibrating collar, which will vibrate when you sleep on your back. We are hoping to try these two treatments in a controlled fashion by adding the collar in different time periods of the trial. Our study hypothesis is that adding the vibrating collar will improve the treatment efficacy. We are hoping to look at the benefits of treatments by looking at the treatment compliance which will be assessed by a chip inserted in the outhguard and by llong at the data obtained by the vibrating collar. We will also look at how your sleepiness scores have improved.
Interventions
Arm 1 MAS only. (a custom fitted trial mandibular advancement splint). This intervention involves a custom built mouth guard built by an orthodontist for the needs of the patient. this will be initally fitted and will have a 2 week period of trial phase and acclimatisation phase. Patients are requested to wear as many hours as possible as tolerated during sleep.
During the active phase of treatment, the patients are advised to wear it for the duration of sleep. The usage will be monitored by a c
Arm 1 MAS only. (a custom fitted trial mandibular advancement splint). This intervention involves a custom built mouth guard built by an orthodontist for the needs of the patient. this will be initally fitted and will have a 2 week period of trial phase and acclimatisation phase. Patients are requested to wear as many hours as possible as tolerated during sleep. During the active phase of treatment, the patients are advised to wear it for the duration of sleep. The usage will be monitored by a chip inserted in the mouthguard.. Arm 2 MAS + POT. (Nightshift sleep positioned, Advanced Brain Monitoring, Inc Carlsbad, CA USA), This will involve the mouth guard as in Arm 1 and inaddition the patients will be given a vibrating collar called a night shift, which will vibrate on supine position. This will be worn in arm 2 of the study. The vibrator is to be worn as long as possible during the night. again the data of usage for 5 nights could be measured via the software of the device. It has capacity to monitor only approximately 5 hrs, hence to monitor for 5 days. Cross over study with a wash out period of 2 weeks.
Sponsors
Shyamala Pradeepan
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Males & Females ages 18 – 60 years 2. Moderate to Severe OSA (Apnoea-Hypopnea Index (AHI) > 15/hr) and 3. Supine dependent OSA (Supine to non-supine AHI ratio > 4) 4. CPAP intolerant/refusal 5. Minimum of ten teeth per dental arch 6. Sufficient dental health (No periodontitis) 7. Free from temporo mandibular joint pain
Exclusion criteria
1. Pregnancy 2. BMI > 35 kg/m2 3. Unstable Angina/ Heart Failure (NYHA Class III or IV)/ Stroke 4. Recent (<6months) AMI or Revascularization Procedure. 5. Significant Arrhythmia or Atrial Fibrillation. 6. Recent (<3 months) exposure to OSA therapy with MAS. 7. Severe OSA who are excessively sleepy ( ESS> 16)with increased risk for driving-related accidents. 8. Regular use of sedatives, narcotics, or psychoactive drugs. 9. Contraindications to oral appliance therapy (periodontal disease or dental caries, less than 10 teeth per dental arch, and exaggerated gag reflex).
Outcome results
None listed