None listed
Conditions
Brief summary
The aim of this study is to determine the effects of the combination therapies (collectively "AD173") on sleep efficiency in patients with OSA. Recently, a combination of medications (AD036) was shown to markedly reduce OSA severity. However, there were signs that sleep quality was reduced (lower arousal threshold). We recently showed that the common sleep promotion aids improve sleep efficiency in OSA and upper airway muscle activity. Thus, the combination of AD173 has the potential to improve sleep efficiency and sleep and breathing variables compared to AD036 alone. Secondary outcomes include the effect of these combined agents on the arousal threshold and other sleep and respiratory parameters. In addition, we will measure sleepiness and next day alertness.
Interventions
Randomised, placebo-controlled, cross-over study (~1 week wash-out between visits):
Arm 1: single dose of AD036 drug combination (2 oral capsules) immediately prior to sleep (single overnight study)
Arm 2: single dose of AD173 drug combination (2 oral capsules) immediately prior to sleep (single overnight study)
Interventions will be administered by a study investigator on each visit just prior to sleep for these acute sleep studies to ensure adherence.
Sponsors
Flinders University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
Otherwise healthy men and women with obstructive sleep apnoea -Adults between 18 to 64 years of age, inclusive - BMI between 18.5 and 40.0 kg/m2, inclusive
Exclusion criteria
1. History of narcolepsy. 2. Clinically significant craniofacial malformation. 3. Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. 4. Clinically significant neurological disorder, including epilepsy/convulsions. 5. History of schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-V (DSM V) or International Classification of Disease tenth edition criteria. 6. History of attempted suicide or suicidal ideation within 1 year prior to screening, or current suicidal ideation. 7. History of clinically significant constipation, gastric retention, or urinary retention, benign prostatic hyperplasia. 8. History of moderate or severe hepatic or renal impairment. 9. History of drug abuse or substance use disorder as defined in DSM-V within 12 months. 10. A significant acute illness or infection requiring medical treatment in the past 30 days. 11. Clinically significant cognitive dysfunction. 12. Untreated narrow angle glaucoma. 13. Women who are pregnant or nursing. 14. Known allergy to any of the study medications. 15. Any medication known to influence breathing, sleep/arousal or muscle physiology. 16. Clausrophobia. 17. Use of medications from the list of disallowed concomitant medications. 18. Treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors, strong cytochrome P450 2D6 (CYP2D6) inhibitors, or monoamine oxidase inhibitors (MAOI) within 14 days of the start of study. 19. Use of another investigational agent within 30 days or 5 half-lives, whichever is longer, prior to dosing. Other Exclusions 20. <5 hours typical sleep duration. 21. Night- or shift-work sleep schedule. 22. Employment as a commercial driver or operator of heavy or hazardous equipment. 23. Smoking more than 10 cigarettes or 2 cigars per day. 24. Unwilling to use contraception during the study (if relevant). 25. Unwilling to avoid alcohol on the days of the study. 26. Unwilling to limit caffeinated beverage intake (e.g., coffee, cola, tea) to 400 mg/day or less of caffeine, not to be used within 3 hours of bedtime on study days. 27. Any condition that in the investigator’s opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation. 28. Participant considered by the investigator, for any reason, an unsuitable candidate to receive the study medications or unable or unlikely to understand or comply with the study design.
Outcome results
None listed