Personal Therapy Comfort Settings Pilot Clinical Study

NCT ID: NCT05376137

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-15

Study Completion Date

2023-09-13

Brief Summary

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350 participants will be enrolled in this study. The target population are patients newly diagnosed with OSA and starting CPAP treatment.

User accessible customizable comfort settings (Response setting, expiratory pressure relief (EPR) on/off and EPR level, and Ramp) will be set to either default (control group), or personalized for that participant (active treatment group).

Usage will be recorded for the first 1 month of CPAP treatment, to determine if customizing comfort settings can improve CPAP compliance

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Default comfort settings

Comfort settings will be set to default (out of the box setttings)

Group Type ACTIVE_COMPARATOR

continuous positive airway pressure (CPAP)

Intervention Type DEVICE

CPAP comfort settings will be modified in the active group to be personalized to each participant

Personalized Therapy Comfort Settings

Comfort settings will be personalized to each user

Group Type EXPERIMENTAL

continuous positive airway pressure (CPAP)

Intervention Type DEVICE

CPAP comfort settings will be modified in the active group to be personalized to each participant

Interventions

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continuous positive airway pressure (CPAP)

CPAP comfort settings will be modified in the active group to be personalized to each participant

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients willing to give written informed consent
* Patients who can read and comprehend English
* Patients who are ≥ 18 years of age
* Patients newly diagnosed with OSA and indicated for CPAP therapy.

Exclusion Criteria

* Patients who have previously used PAP therapy
* Patients who require a bilevel device
* Patients who are or may be pregnant

\* Patients who are unable to attend follow up appointments
* Patients 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
* Patients believed to be unsuitable for inclusion by the researcher
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ResMed

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeff Armitstead, PhD

Role: PRINCIPAL_INVESTIGATOR

ResMed

Locations

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ResMed Centre for Healthy Sleep

Bella Vista, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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MA11022022

Identifier Type: -

Identifier Source: org_study_id

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