Status:
UNKNOWN
An Exploratory Investigation of the Use of Drive App to Measure Sleep Parameters in Users of CPAP Therapy
Lead Sponsor:
ResMed
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 issu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04500327
Start Date
June 25 2020
End Date
June 1 2021
Last Update
August 5 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
ResSleep
Sydney, New South Wales, Australia, 2153