NCT04500327

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
OTHER	Drive app	The Drive app will be used to monitor sleep metrics for users of CPAP therapy.
DEVICE	Non contact motion sensor	The non contact motion sensor will be used as a reference to the Drive app i.e. Drive app overnight recordings will be compared to the non contact motion sensor overnight recordings.

Timeline

• Start date: 2020-06-25
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2020-08-05
• Last updated: 2020-08-05

Locations

1 site across 1 country: Australia