Effects of noradrenergic and antimuscarinic agents on obstructive sleep apnoea (OSA) and upper airway muscle activity during sleep

Phase 2

Completed

• Conditions: Obstructive sleep apnoea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12617001326381
• Lead Sponsor: euroscience Research Australia (NeuRA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-15
• Study Completion: 2019-04-02
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Otherwise healthy men and women with obstructive sleep apnoea aged 18-65 years

Exclusion Criteria

-Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
-Patients with any other medical condition which may interfere in the evaluation of the study.
-Patients with a previous history of addiction to alcohol or drugs.
-Patients taking medications known to affect sleep or muscle activity.

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)]

Secondary Outcome Measures

Name	Time	Method
Pharyngeal muscle activity during sleep using intramuscular electromyography (EMG).[Single acute overnight sleep studies (placebo vs. drug)];Sleep efficiency from the overnight polysomnogram[Single acute overnight sleep studies (placebo vs. drug)];Minute ventilation measured using a nasal mask and pneumotachograph.[Single acute overnight sleep studies (placebo vs. drug)];Hypoxemia from the overnight polysomnogram measured using oximetry[Single acute overnight sleep studies (placebo vs. drug)]