Clinical trial NCT04500327: An Exploratory Investigation of the Use of Drive App to Measure Sleep Parameters in Users of CPAP Therapy
Official title: An Exploratory Investigation of the Use of Drive App to Measure Sleep Parameters in Users of CPAP Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2020-08-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Participants willing to give written informed consent
* Participants who can read and comprehend English
* Participants who ≥ 18 years of age
* Participants established on CPAP therapy for the treatment of OSA for ≥ 6 months
* Participants who are able to set up the trial devices (ideally on a bedside table) with the following criteria:

  * Trial devices must be 10 cm higher than the mattress
  * Approx. 40 cm from the person's chest in bed
* Participants that have access to WI-FI in their home environment
* Participants who can trial the device for up to 7 nights
* \*Participants who have been compliant (average of ≥4 hours of usage) to therapy for up to 7 nights of use

  * Note: the most recent consecutive 7 nights within the last 30 days

Exclusion Criteria:

* Participants using Bilevel flow generators
* Participants who are or may be pregnant, breastfeeding or within 6 weeks postpartum (which are known to cause significant sleep disruption)
* Participants with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury.
* Participants believed to be unsuitable for inclusion by the researcher
* \*Participants using one of the following devices or Apps during the research period, or any other sleep tracking devices: SPlus, SleepScore app, SleepScore Max.

  * Note: If the participant uses the devices or apps above and they agree to delete/not use them during study period, they can be included in the study.

Primary outcomes:
measure: Identify any failures when using the Drive app for users of CPAP therapy
timeFrame: 12 months (includes Phase 1 and Phase 2 and interim data analysis)
Secondary outcomes:
measure: Evaluate usability of the Drive app
timeFrame: 12 months (includes Phase 1 and Phase 2 and interim data analysis)
measure: Compare subjective sleep quality data with data generated on the app.
timeFrame: 12 months (includes Phase 1 and Phase 2 and interim data analysis)
measure: Compare the Drive app sleep data to data from the reference devices.
timeFrame: 12 months (includes Phase 1 and Phase 2 and interim data analysis)
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: ResSleep
state: New South Wales
Study officials:
References: