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OpenTrials
Completed

NCT Number: NCT05376137

Personal Therapy Comfort Settings Pilot Clinical Study

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ResMed Centre for Healthy Sleep

Bella Vista, New South Wales, 2153, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Positive Airway Pressure (CPAP)

Device

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

Primary outcomes

  1. Comparison of treatment continuance between the control group and active treatment group.

    Time frame: 4 weeks after commencement of CPAP

    Patients who drop off treatment (stop using CPAP treatment) in each group will be compared after 1.5 months of CPAP treatment.

Secondary outcomes

  1. comparison of compliance between the control group and active treatment group

    Time frame: 4 weeks after commencement of CPAP

    Usage will be compared between the two groups

  2. Treatment efficacy

    Time frame: 4 weeks after commencement of CPAP

    Residual Apnea-hypopnea index will be compared between the two groups

  3. Mask leak

    Time frame: 4 weeks after commencement of CPAP

    Mask leak will be compared between the two groups

  4. Settings changes

    Time frame: 4 weeks after commencement of CPAP

    Number of comfort settings changes will be compared between the two groups

  5. Ad hoc contacts

    Time frame: 4 weeks after commencement of CPAP

    Number of ad hoc contacts between participants and clinicians will be compared between the two groups

Other outcomes

  1. Exploratory analysis of long term usage

    Time frame: 3,6,9, 12 months after commencement of CPAP

    CPAP usage will be compared at 3, 6, 9 and 12 months for patients who have consented, as an exploratory analysis of long term usage

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 17, 2022
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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