Personal Therapy Comfort Settings Pilot Clinical Study

Obstructive Sleep Apnea Clinical Trial

Official title:

Personal Therapy Comfort Settings Pilot Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05376137
• Other study ID #: MA11022022
• Status: Completed
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: September 13, 2023

Study information

• Verified date: November 2023
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 13, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• continuous positive airway pressure (CPAP)
CPAP comfort settings will be modified in the active group to be personalized to each participant

Locations

Country	Name	City	State
Australia	ResMed Centre for Healthy Sleep	Bella Vista	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory analysis of long term usage	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	3,6,9, 12 months after commencement of CPAP
Primary	Comparison of treatment continuance between the control group and active treatment group.	Patients who drop off treatment (stop using CPAP treatment) in each group will be compared after 1.5 months of CPAP treatment.	4 weeks after commencement of CPAP
Secondary	comparison of compliance between the control group and active treatment group	Usage will be compared between the two groups	4 weeks after commencement of CPAP
Secondary	Treatment efficacy	Residual Apnea-hypopnea index will be compared between the two groups	4 weeks after commencement of CPAP
Secondary	Mask leak	Mask leak will be compared between the two groups	4 weeks after commencement of CPAP
Secondary	Settings changes	Number of comfort settings changes will be compared between the two groups	4 weeks after commencement of CPAP
Secondary	Ad hoc contacts	Number of ad hoc contacts between participants and clinicians will be compared between the two groups	4 weeks after commencement of CPAP