A proof of concept, multi-centre evaluation of the potential beneficial effects of CB0011 when combined with CB0012 for the treatment of obstructive sleep apnea.
Phase 1
Completed
- Conditions
- Obstructive Sleep ApneaRespiratory - Sleep apnoea
- Registration Number
- ACTRN12605000688684
- Lead Sponsor
- Cypress Bioscience, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Subjects must have a current diagnosis of Obstructive Sleep Apnea, have an apnea-hypopnea index (AHI) of between 10-40 (using a strict definition of hypopnea), with a calculated BMI equal or less than 34 at the time of study entry.
Exclusion Criteria
No exclusion criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in Obstructive Sleep Apnea as measured by the patient apnea hypopnea index score (AHI).[Parameters measured at baseline and week four (or early termination) by overnight polysomnography and between three and five nights per week by patients utilising an ambulatory home monitoring device.];Changes in Obstructive Sleep Apnea as measured by the respiratory disturbance index (RDI).[Parameters measured at baseline and week four (or early termination) by overnight polysomnography and between three and five nights per week by patients utilising an ambulatory home monitoring device.];Changes in Obstructive Sleep Apnea as measured by oxygen desaturation index (ODI).[Parameters measured at baseline and week four (or early termination) by overnight polysomnography and between three and five nights per week by patients utilising an ambulatory home monitoring device.]
- Secondary Outcome Measures
Name Time Method Changes in daytime sedation, quality of life, sleep quality, mood, fatigue and weight measured.[Measured at baseline, week two, and week four or early termination.]