Mouthguard and positional trainer( vibrating collar) in supine sleep apnoea..

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2018
INTERVENTION: 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. CONDITION: Ostructive sleep apnoea Positional obstructive sleep apnoea positional sleep apnoea supine predominant sleep apnoea PRIMARY OUTCOME: Polysomnography – Residual apnoea‐ hypopnea index(AHI) Residual Oxygen desaturation index(ODI) on each treatment arm) ; SECONDARY OUTCOME: Objective MAS compliance measurements. There will be thermo chip implanted in the MAS which will record the hours of usage of the device. The average usage of the MAS over a period of 1 month will be analysed. ; ; Change in Epworth sleepiness score (ESS) from baseline. ; 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
Epistemonikos ID: 25324689a1aa2eaf0f9a498c1ef93aee501106df
First added on: Aug 24, 2024