A novel device in the treatment of Obstructive Sleep Apnea and Snoring.
- Conditions
- Obstructive Sleep Apnoea (OSA)SnoringRespiratory - Sleep apnoea
- Registration Number
- ACTRN12613000009718
- Lead Sponsor
- Sleepy Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 50
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method