Evaluation of LGT-371 as a treatment for obstructive sleep apnoea: A pilot study

Phase 1

Completed

• Conditions: Obstructive sleep apnoea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12618001579280
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-24
• Study Completion: 2023-05-17
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

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

Inclusion Criteria

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

Exclusion Criteria

•Medical and concurrent medication exclusions in accordance with the most recently published Summary of Product Characteristics (SPC) for LGT-371
•Concurrent or recent (within the past month) use of any medication known to influence sleep, arousal, circadian rhythm, breathing or muscle function
•For women: Pregnancy or breast feeding.
•Occupation or life situation that may be put at risk by participation in the study
•History of shift work or rotating shifts in the month prior
•Involvement as a driver in a motor vehicle accident during the past 2 years where the cause of the accident was attributed to driver sleepiness
•Inability to sleep supine

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)];Loop Gain (LG) determined during sleep from the overnight polysomnogram [measured using the method described by Terrill et al (2015)].<br>[ Single acute overnight sleep studies (placebo vs. drug)]