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

NCT04500327 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-08-05

No results posted yet for this study

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

Interventions

OTHER

Drive app

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

DEVICE

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.

Sponsors & Collaborators

  • ResMed

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-25
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Australia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04500327 on ClinicalTrials.gov