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Personal Therapy Comfort Settings Pilot Clinical Study

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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

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)

Trial contacts and locations

1

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Central trial contact

Alison Wimms, PhD

Data sourced from clinicaltrials.gov

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