An Exploratory Investigation of the Use of Drive App to Measure Sleep

Status Recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the usability and suitability of the Drive app (app under test) to measure sleep parameters during CPAP use.

This is a prospective, non-randomized, single arm exploratory study without blinding.

Current users of CPAP therapy will be recruited for this study and will be provided with a smartphone (app under test installed) and a non-contact motion sensor in their home environment. These devices will measure sleep metrics such as sleep stages and breathing metrics that may be associated with sleep disordered breathing. Usage and setup instructions will be provided for the study.

Participants will contribute up to 7 overnight recordings in the home environment and will complete daily questionnaires detailing their experience.

The study may be completed in two distinct phases, with an analysis performed after each phase. Each phase is expected to last up to six weeks with the overall study duration taking up to 12 months.

Clinical Trial Description

The study may be completed in two distinct phases, with an analysis performed after each phase.

Phase 1 (Exploratory): A minimum of 10 and up to 12 participants will be recruited to identify any issues in using the app when used in conjunction with CPAP therapy (e.g. missed signals, inappropriate classification of breathing signals).

Phase 2 (Iterative Updates): Where changes to the algorithm or user interface are required, an additional 30 and up to 35 participants may be tested to provide design confidence. Conversely, if substantial issues are experienced and the time and effort required to address the issues is sufficiently large, the study may terminate before completion of phase 2.

Each phase is expected to last up to six weeks with the overall study duration taking up to 12 months.

Participants will be required to visit ResMed twice. The first visit will involve briefing of the study, consent form signatures, briefing on trial equipment and setup/usage instructions. The second (last) visit will involve going through the daily questionnaires with participants, collecting trial equipment and providing reimbursement for the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04500327
Study type	Interventional
Source	ResMed
Contact	Neha Banodkar
Phone	(02) 8884 2656
Email	neha.banodkar@resmed.com.au
Status	Recruiting
Phase	N/A
Start date	June 25, 2020
Completion date	June 2021

View Details

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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.

An Exploratory Investigation of the Use of Drive App to Measure Sleep Parameters in Users of CPAP Therapy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms