A Phase 2a randomised controlled trial measuring the effects on apnoea hypopnoea index (AHI) with nocturnal IHL-42X versus placebo in adults with obstructive sleep apnoea (OSA)

Cannvalate0 sites30 target enrollmentAugust 9, 2019

Overview

No summary available.

Registry

who.int

Start Date

August 9, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Cannvalate

•Aged between 21 and 65 years
•Evidence of an Apnoea Hypopnea Index greater than or equal to 15 or less than or equal to 50\. This criteria will be subject to the potential participant either being recently referred to the Austin sleep laboratory for ‘likely OSA’ or having a pre\-existing diagnosis of OSA from a physician. This will be verified by the results of the PSG post V1, before randomisation occurs.
•Have experimented with cannabinoids previously (self\-disclosure). This includes any cannabis product (marijuana, skunk, ‘weed’)
•No known allergic reaction to cannabis products with previous use
•Ability to speak and read English
•Have no history of past substance abuse or current abuse of illicit drugs
•Physically well with no severe psychiatric, cardiac, renal, endocrine, gastrointestinal, or bleeding disorders
•Not currently pregnant or lactating
•Not taken any form of medication within 5 days of admission (except for prophylactic antibiotics, contraceptive pill or other routine medications to treat benign conditions, such as antibiotics to treat acne).
•Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial

•Aged under 21 or over 65 years
•AHI of under 15 or over 50, or no doctors referral or diagnosis of sleep disorder
•Other pre\-existing sleep disorder (restless legs syndrome, narcolepsy, parasomnias etc.)
•Currently using a positive airway pressure device (e.g. CPAP, VPAP), or other treatment for OSA including mandibular advancement splint, or positional device
•ESS \< 7 (excludes non\-sleepy participants)
•Inability to speak or read English
•Non\-compliance with study treatment following placebo run\-in (missing greater than 20% of the treatment doses)
•History of drug or substance abuse or current illicit drug abuse
•Not physically well, or a history of severe psychiatric, cardiac, endocrine, renal, gastrointestinal, or bleeding disorders
•Currently pregnant or breastfeeding