None listed
Conditions
Brief summary
Royal North Shore Hospital is currently trialing a new treatment for Obstructive Sleep Apnoea and snoring. The trial is for 4 weeks, and will involve wearing the device every night. The study will assess the safety and efficacy of the device.
Interventions
The Tongue Advancement Retainer Device has been designed to decrease the severity of OSA and Snoring by maintaining the tongue in an extended position, thus preventing the tongue from falling backwards during sleep, preventing the engagement with the soft palate and airway.
Participants will wear the device nightly for a 4 week period. The device will be fitted by the participant before going to sleep and removed upon waking. The clinician will instruct the participant on how to correctly fit
The Tongue Advancement Retainer Device has been designed to decrease the severity of OSA and Snoring by maintaining the tongue in an extended position, thus preventing the tongue from falling backwards during sleep, preventing the engagement with the soft palate and airway. Participants will wear the device nightly for a 4 week period. The device will be fitted by the participant before going to sleep and removed upon waking. The clinician will instruct the participant on how to correctly fit the device, and choose the most appropriate size for the participants mouth. A polysomnogram (PSG), otherwise known as a sleep study, will be conducted at baseline and end of study to assess efficacy of the device. For the sleep study the participant attends the sleep lab in the early evening, and over the next 1–2 hours is introduced to the setting and "wired up" so that multiple channels of data can be recorded when he/she falls asleep. The recording will measure breathing, heart rate, brain activity, and body movement all night. During the study, the technician observes sleep activity by looking at the video monitor and the computer screen that displays all the data second by second. The test is completed and the participant goes home around 7 a.m.
Sponsors
Sleepy Inc.
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 65 Years
Healthy volunteers
No
Inclusion criteria
Aged 18-65 AHI greater than or equal to 10 but less than or equal to 60 (<10 AHI <60/hr) Fluency in both written and spoken English Complete set of lower anterior incisors with no evidence of periodontal disease or mobility and the ability to floss between teeth
Exclusion criteria
Central sleep apnea events >10% of the total events Evidence of Cheyne stokes breathing Currently on treatment for OSA or OSA treatment discontinued less than 3 months prior. Currently on regular treatment with prescription hypnosedatives or prescription stimulants Very severe OSA, defined as AHI>60/hour and/or minimum oxygen saturation <75% Need for immediate initiation of treatment as assessed by physician (e.g. Excessive sleepiness posing driving risk) Previous upper airway surgery for OSA (other than nasal surgery) Evidence of periodontal disease or tooth mobility Severe nasal obstruction or enlarged tonsils based on clinical assessment Unstable cardiovascular disease (untreated hypertension acceptable). Inability to tolerate oral device due to oral condition or claustrophobia as determined by the study investigator Pregnant/Breast Feeding Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as co-existent other sleep disorder, psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with study requirements. Inability to understand the English language
Outcome results
None listed