Clinical trial NCT04744038: Evaluating the Efficacy of PAP Therapy for Treating OSA in the Home Environment
Official title: Evaluating the Efficacy of Positive Airway Pressure Therapy for Treating Obstructive Sleep Apnea in the Home Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea (OSA)
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2021-02-08
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will take between 4-6 months (with first patient first visit to last patient last visit expected to span 3-4 months across all study sites). Each participant will use the investigational PAP device with their own mask for a period of up to 7 nights and will complete a series of questionnaires upon completion. The study will evaluate the usability and efficacy of the investigational device in the intended use environment by the intended use population.

Detailed description: A new PAP device has been developed by ResMed which includes an improved humidification system, a new user interface and optimized workflows. This study will assess the efficacy and usability of the new PAP device in an OSA population.

This is a prospective, open-label, single arm study, multi-site study to assess the usability and efficacy of investigational device in the home environment.

Recruitment Recruitment will be done via phone calls/ SMS messages/ emails. Participants will be explained the details of the study and those who wish to take part will be invited to a ResMed clinic or selected site for the first study visit (As detailed in section 7).

Visit 1 Participants will provide written informed consent (as per section 6.1). If eligible, baseline participant demographics will be collected. Participants will be shown the investigation device. If the participant is happy to proceed the investigational device will be set-up to be exactly the same as their current CPAP device, and the participant will take it home to use in place of their own device.

Visit 2 At the conclusion of the 7 nights of use, the participant will be asked to fill in a questionnaire documenting their experience with the investigational device. The participant will return all study equipment to the researcher. The questionnaires will be reviewed. This concludes the participation in the study.

Eligibility criteria: Inclusion Criteria:

* Patients willing to give written informed consent
* Patients who can read and comprehend English
* Patients who ≥ 18 years of age
* Patients being established on PAP therapy for the treatment of OSA for ≥ 6 months
* Patients currently using AirSense10 (as their primary device)
* Patients currently using an appropriate mask system (AirFit F20, AirFit P10, AirFit N20, AirFit N30i, AirFit F30i or AirFit P30i)
* Patients who can trial the investigational device for up to 7 nights
* Patients who have been compliant to therapy (average of ≥4 hours of usage) for the previous 7 nights of use\* \*the most recent consecutive 7 nights within the last 30 days

Exclusion Criteria:

* Patients using Bilevel flow generators
* Patients who are or may be pregnant
* 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
* Patients who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (Non-ferrous implants may be acceptable)
* Patients using supplemental oxygen

Primary outcomes:
measure: Usability
timeFrame: 1 week
Secondary outcomes:
measure: Apnea Hypopnea Index (AHI)
timeFrame: 1 week
measure: Usage-Positive Airway Pressure (PAP) Device parameters
timeFrame: 1 week
measure: Leak-Positive Airway Pressure (PAP) Device parameters
timeFrame: 1 week
measure: Pressure-Positive Airway Pressure (PAP) Device parameters
timeFrame: 1 week
measure: Acoustic Signals
timeFrame: 1 week
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sleep Data
state: California
city: Sydney
country: Australia
facility: ResMed BELLA VISTA
state: New South Wales
Study officials:
References: