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

NCT04500327 | Unknown DMC

• 1 other identifier: DHT-20-04-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Identify any failures when using the Drive app for users of CPAP therapy

  This will be based on: 1. Subjective data from daily questionnaires sent out to participants 2. 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.

  12 months (includes Phase 1 and Phase 2 and interim data analysis)

Secondary Outcomes (3)

• Evaluate usability of the Drive app

  12 months (includes Phase 1 and Phase 2 and interim data analysis)

• Compare subjective sleep quality data with data generated on the app.

  12 months (includes Phase 1 and Phase 2 and interim data analysis)

• Compare the Drive app sleep data to data from the reference devices.

  12 months (includes Phase 1 and Phase 2 and interim data analysis)

Study Arms (1)

CPAP users

EXPERIMENTAL

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: Drive app; Device: Non contact motion sensor

Interventions

Drive app OTHER

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

CPAP users

Non contact motion sensor DEVICE

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.

CPAP users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

ResSleep

Sydney, New South Wales, 2153, Australia

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Neha Banodkar

CONTACT

(02) 8884 2656; neha.banodkar@resmed.com.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: August 5, 2020
• Study Start: June 25, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: August 5, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)