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Broad Health Condition Respiratory
Specific Health ConditionSleep apnoea
The Alfred - Melbourne
3004 - Melbourne
6009 - Crawley
Anticipated date of first participant enrolment19/10/2020
This is a randomised crossover study to determine the therapeutic benefit of a combination of dronabinol and acetazolamide in subjects with suspected or diagnosed mild to moderate Obstructive Sleep Apnoea (OSA). Subjects will be required to undergo five sleep tests. Prior to each sleep test the Subjects will complete questionnaires to assess daytime somnolence, mood and quality of life. The first sleep test will confirm OSA and establish baseline levels for AHI, daytime somnolence, mood and quality of life. Once OSA is confirmed Subjects will be randomised into one of six treatment arms. All Subjects will undergo four treatment periods where they will receive treatment one of placebo or low, medium or high dose combination of dronabinol with acetazolamide. All subjects will receive all treatments over the course of the study but the order or treatment periods will be random. Each treatment will last for seven nights with a seven-night washout period between treatments. On night 7 of each treatment period the Subjects will undergo a sleep study using a polysomnography (PSG) machine at the sleep clinic. Sleepiness, mood and quality of life questionnaires with completed prior to PSG set up on night 7. AHI, daytime somnolence, mood and quality of life scores will be compared to baseline across the 4 treatments to establish the optimal dose for the therapeutic benefit for the combination of dronabinol with acetazolamide for treatment of OSA.
Key inclusion criteria
Aged between 21 and 65 years - Evidence of OSA based on AHI greater than or equal to 15. The first PSG study will be analysed within 2 business days to confirm AHI criteria. - No known allergic reaction to cannabis products with previous use (self-disclosure). - No known allergic reaction to sesame oil (dronabinol is formulated in sesame oil) - No know allergic reaction to acetazolamide or other sulphonamides. - Have no history of past substance abuse or current abuse of illicit drugs - Physically well, in the opinion of the investigator, with no severe psychiatric, cardiac, renal, endocrine, gastrointestinal, or bleeding disorders - If male, agree to be sexually abstinent or agree to use two approved methods of contraception when engaging in sexual activity from study Visit 1 through to the end of the study. Subjects must agree to use two approved methods of contraception for 10 days following the last administration of the study drug, and not donate sperm during this same period of time. In the event that the sexual partner is surgically sterile, contraception is not necessary. - Females of non-childbearing potential with serum FSH levels greater than 40mlU/ml are either postmenopausal or have undergone one of the following sterilization procedures at least 6 months prior to Visit 1; o Bilateral tubal ligation o Hysterectomy o Hysterectomy with unilateral or bilateral oophorectomy o Bilateral oophorectomy - Females of childbearing potential that are not currently pregnant or lactating - Not taken any vitamins, herbal remedies or supplements within 5 days of admission - Voluntarily consent to participate in the study and complete all study required tasks, as instructed by the protocol, including the completion of questionnaires and logs - Willing to abstain from driving a vehicle during the treatment periods plus 2 days after (4 x 9 days) - Willing and able to self-administer two capsules by mouth, at the clinic visit or 60 minutes before bedtime, each night during the treatment periods of the study (4 x 7 days)
Minimum age21 Years
Maximum age65 Years
GenderBoth males and females
Key exclusion criteria
-Other pre-existing sleep disorder (restless legs syndrome, narcolepsy, parasomnias etc.) - Currently using CPAP, or other treatment for OSA including mandibular advancement splint, or positional device - Severe blood O2 desaturation as measured in V1 PSG. - Body Mass Index (BMI) greater than 45 - ESS less than 7 (excludes non-sleepy participants) -History of known hypokalmia (low blood potassium), hyponatremia (low blood sodium), hypocholremic acidosis, adrenal insufficiency, impaired kidney function, marked liver disease or impaired liver function, within the last 6 months.
Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Incannex Healthcare Limited
Primary Sponsor Address: Level 39, Rialto South Tower, 525 Collins Street, Melbourne VIC 3000
Primary Sponsor Country: Australia
Contact person for information and recruitmentMr
Epilepsy Research Unit – 4 Centre Block, Level 4 The Alfred Hospital 55 Commercial Rd, Melbourne VIC 3004
+61 3 9076 2029
Email contact J.Germaine@alfred.org.auAustralia