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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04500327




Registration number
NCT04500327
Ethics application status
Date submitted
26/05/2020
Date registered
5/08/2020
Date last updated
5/08/2020

Titles & IDs
Public title
An Exploratory Investigation of the Use of Drive App to Measure Sleep Parameters in Users of CPAP Therapy
Scientific title
An Exploratory Investigation of the Use of Drive App to Measure Sleep Parameters in Users of CPAP Therapy
Secondary ID [1] 0 0
DHT-20-04-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Drive app
Treatment: Devices - Non contact motion sensor

Experimental: CPAP users - 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.


Other interventions: Drive app
The Drive app will be used to monitor sleep metrics for users of CPAP therapy.

Treatment: Devices: 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.

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
12 months (includes Phase 1 and Phase 2 and interim data analysis)
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
12 months (includes Phase 1 and Phase 2 and interim data analysis)
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
12 months (includes Phase 1 and Phase 2 and interim data analysis)
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
12 months (includes Phase 1 and Phase 2 and interim data analysis)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Device Feasibility
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
ResSleep - Sydney
Recruitment postcode(s) [1] 0 0
2153 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ResMed
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04500327
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Neha Banodkar
Address 0 0
Country 0 0
Phone 0 0
(02) 8884 2656
Fax 0 0
Email 0 0
neha.banodkar@resmed.com.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04500327