Development of Advanced Leak Detection Technologies for Positive Airway

Status Recruiting

Clinical Trial Summary

This study will take between 1-2 months (with first patient first visit to last patient last visit). Each participant will use the supplied PAP device and mask for a period of up to 14 nights. Participants will complete a series of questionnaires. The study will collect data to support the development of an advance leak detection technology.

Clinical Trial Description

The investigation device is designed to collect leak patterns which will be analysed to develop an advanced leak detection technology to help users/patients to troubleshhot therapy issues. This will be a multi-centre, multiphase, single arm study. The study will be conducted in the home environment. Recruitment Recruitment will be done via phone calls/ SMS messages/ emails. Participants will be explained the details of the trial and those who wish to take part will be invited to ResMed for the first study visit. Visit 1 Participants will provide written informed consent. If eligible, baseline participant demographics will be collected. Participants will be shown the investigation equipment. If the participant is happy to proceed, the therapy and comfort settings of the trial PAP device will be set-up to match their current PAP device and a mask similar to the participant's current mask will be provided to take home and be use in place of their own equipment. Visit 2 After completing 7 days of the trial participants will return to the ResMed. The researcher will review the questionnaire and data quality with the participant. Visit 2 may not be performed or completed via digital platform. For Phase 2 of this study. Visit 2 may not be completed as confidence in the system set up is achieved via Phase 1. Visit 3 After completing another 7 days of the trial, participants will return to the ResMed. The participant will return all trial equipment researcher. The participants' questionnaire responses and data will be reviewed. This concludes the participation in the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04741854
Study type	Interventional
Source	ResMed
Contact	Sumudu M Herath
Phone	0435 528 615
Email	sumudu.herath@resmed.com.au
Status	Recruiting
Phase	N/A
Start date	August 26, 2020
Completion date	April 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Development of Advanced Leak Detection Technologies for Positive Airway Pressure Devices Therapies

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms