The effects of AD047 and AD282 on obstructive sleep apnoea (OSA)

Phase 1

Completed

• Conditions: Obstructive sleep apnoea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12618001181291
• Lead Sponsor: Apnimed

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-17
• Study Completion: 2019-02-19
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

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

Inclusion Criteria

Otherwise healthy men and women with obstructive sleep apnoea aged 18 years or older.

Exclusion Criteria

Exclusion Criteria:
•Any chronic medical condition other than well controlled hypertension, hyperlipidemia, diabetes.
•Any medication known to influence breathing, sleep/arousal or muscle physiology.
•Claustrophobia.
•Inability to sleep supine.
•Known allergy to study medications
•Benign prostatic hyperplasia or urinary retention
•Individuals with underlying cardiac disease, such as arrhythmias.
•Individuals taking psychiatric medications, such as tricyclic antidepressants, or any of the studied medications for medical care.
•History of moderate or severe hepatic or renal impairment.
•History of seizures.
•For women: Pregnancy.

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) ]