Personal Therapy Comfort Settings Pilot Clinical Study

ResMed

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: continuous positive airway pressure (CPAP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05376137

MA11022022

Details and patient eligibility

About

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

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups

Default comfort settings

Active Comparator group

Description:

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

Treatment:

Device: continuous positive airway pressure (CPAP)

Personalized Therapy Comfort Settings

Experimental group

Description:

Comfort settings will be personalized to each user

Treatment:

Device: continuous positive airway pressure (CPAP)