The effects of AD098, AD153 and AD639 on obstructive sleep apnoea (OSA)

Phase 1

Completed

• Conditions: Obstructive Sleep Apnoea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12618001499279
• Lead Sponsor: Apnimed

Brief Summary

There was no significant effect of either drug combinations on reducing OSA severity or improving any of the key physiological causes of OSA. However, duloxetine+oxybutynin did significantly increase the fraction of hypopnoeas to apnoeas compared to placebo (p = 0.02; d = 0.54). In addition, duloxetine+oxybutynin reduced time in REM sleep (p = 0.009; d = 1.03) which was positively associated with a reduction in OSA severity (R2 = 0.62; p = 0.02). In summary - neither drug combination significantly improved OSA severity or modified the key OSA physiological causes of OSA when administered as a single dose to unselected OSA. patients.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-06
• Study Completion: 2019-07-17
• Last Update Posted: 19 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Otherwise healthy men and women with moderate-to-severe obstructive sleep apnoea

Exclusion Criteria

•Any chronic medical condition other than controlled hypertension, hyperlipidemia, diabetes.
•Any medication known to influence breathing, sleep/arousal or muscle physiology.
•Claustrophobia.
•Inability to sleep supine.
•BMI>45
•Central apnea index >5 events/h
•Tonsillar hypertrophy or craniofacial malformation
•Allergy to lidocaine, oxymetazoline HCl or study medications
•For women: Pregnancy or breast feeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep apnoea severity using the apnoea/hypopnoea index from the overnight polysomnogram[Single acute overnight sleep studies (placebo vs. drug)]