Back to resultsAn Exploratory Investigation of the Use of Drive App to Measure Sleep Parameters in Users of CPAP Therapy
Primary Purpose
Obstructive Sleep Apnea
Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Drive app
Non contact motion sensor
Sponsored by
About this trial
This is an interventional device feasibility trial for Obstructive Sleep Apnea
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.
Sites / Locations
- ResSleepRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CPAP users
Arm Description
The Drive app will be used by CPAP users to identify any major issues with the usability and functionality of the app when used with CPAP therapy.
Outcomes
Primary Outcome Measures
Identify any failures when using the Drive app for users of CPAP therapy
This will be based on:
Subjective data from daily questionnaires sent out to participants
Comparison between Drive app data with the non contact motion sensor and CPAP data
The questionnaire has yes/no questions and a likert scale (from 0-10) that participants fill in to indicate how representative each nights sleep hypnogram is. For e.g. if the participant was awake between 12am-1am but the app reports that the subject is in deep sleep, this will be captured in the questionnaire.
Metrics including accuracy, correlation, total cohens kappa will be used for each signal recorded by the app which will be used to compare to the data from the reference devices.
Secondary Outcome Measures
Evaluate usability of the Drive app
This will be based on subjective data from daily questionnaires sent out to participants.
This data will be captured from comments by the participants in the daily questionnaires.
Compare subjective sleep quality data with data generated on the app.
This will be based on subjective data from daily questionnaires sent out to participants.
The questionnaire has yes/no questions and a likert scale (from 0-10) that participants fill in to indicate how representative each nights sleep hypnogram is. For e.g. if the participant was awake between 12am-1am but the app reports that the subject is in deep sleep, this will be captured in the questionnaire.
Compare the Drive app sleep data to data from the reference devices.
Analyses will be performed to compare the Drive app data with the non contact motion sensor and CPAP device.
Metrics including accuracy, correlation, total cohens kappa will be used for each signal recorded by the app which will be used to compare to the data from the reference devices.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04500327
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 25, 2020 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CPAP users
Arm Type
Experimental
Arm Description
The Drive app will be used by CPAP users to identify any major issues with the usability and functionality of the app when used with CPAP therapy.
Intervention Type
Other
Intervention Name(s)
Drive app
Intervention Description
The Drive app will be used to monitor sleep metrics for users of CPAP therapy.
Intervention Type
Device
Intervention Name(s)
Non contact motion sensor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Identify any failures when using the Drive app for users of CPAP therapy
Description
This will be based on:
Subjective data from daily questionnaires sent out to participants
Comparison between Drive app data with the non contact motion sensor and CPAP data
The questionnaire has yes/no questions and a likert scale (from 0-10) that participants fill in to indicate how representative each nights sleep hypnogram is. For e.g. if the participant was awake between 12am-1am but the app reports that the subject is in deep sleep, this will be captured in the questionnaire.
Metrics including accuracy, correlation, total cohens kappa will be used for each signal recorded by the app which will be used to compare to the data from the reference devices.
Time Frame
12 months (includes Phase 1 and Phase 2 and interim data analysis)
Secondary Outcome Measure Information:
Title
Evaluate usability of the Drive app
Description
This will be based on subjective data from daily questionnaires sent out to participants.
This data will be captured from comments by the participants in the daily questionnaires.
Time Frame
12 months (includes Phase 1 and Phase 2 and interim data analysis)
Title
Compare subjective sleep quality data with data generated on the app.
Description
This will be based on subjective data from daily questionnaires sent out to participants.
The questionnaire has yes/no questions and a likert scale (from 0-10) that participants fill in to indicate how representative each nights sleep hypnogram is. For e.g. if the participant was awake between 12am-1am but the app reports that the subject is in deep sleep, this will be captured in the questionnaire.
Time Frame
12 months (includes Phase 1 and Phase 2 and interim data analysis)
Title
Compare the Drive app sleep data to data from the reference devices.
Description
Analyses will be performed to compare the Drive app data with the non contact motion sensor and CPAP device.
Metrics including accuracy, correlation, total cohens kappa will be used for each signal recorded by the app which will be used to compare to the data from the reference devices.
Time Frame
12 months (includes Phase 1 and Phase 2 and interim data analysis)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neha Banodkar
Phone
(02) 8884 2656
Email
neha.banodkar@resmed.com.au
Facility Information:
Facility Name
ResSleep
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2153
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neha Banodkar
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Exploratory Investigation of the Use of Drive App to Measure Sleep Parameters in Users of CPAP Therapy
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