A randomized, double blind, placebo-controlled trial to assess the efficacy of LipZip in reducing mouth breathing on continuous positive airway pressure (CPAP) treatment.

Not Applicable

• Conditions: Obstructive sleep apnoea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12614000905662
• Lead Sponsor: Z Respiratory and Sleep Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients diagnosed with obstructive sleep apnea with a minimum Apnea Hypopnea Index (AHI) of 15 events/hour. 2. Patients currently on CPAP treatment with known history of mouth breathing

Exclusion Criteria

1. Patients on auto-adjusting PAP machine.
2. Patients with retrognathia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in mouth breathing as measured by the leak data from the CPAP device as assessed in all participants at both timepoints[at 2 and 6 weeks after randomisation]

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale responses on the ease of use of LipZip and is assessed in all participants at both timepoints[at 2 and 6 weeks after randomisation];CPAP adherence as measured by average CPAP use on LipZip, assessed in all participants at both timepoints, by downloading the memory card in the device.[at 2 and 6 weeks after randomization]