NCT04744038

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 12, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2021

Completed
Last Updated

July 13, 2021

Status Verified

February 1, 2021

Enrollment Period

7 months

First QC Date

January 4, 2021

Last Update Submit

July 11, 2021

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (1)

  • Usability

    Subjective ratings of the Usability of the Pacific device after using it in the home environment for up to 7 nights. Ratings will be collected using an 11 point Likert Scale where a score of 10 is considered very favorable, and a score of 0 is very unfavorable.

    1 week

Secondary Outcomes (5)

  • Apnea Hypopnea Index (AHI)

    1 week

  • Usage-Positive Airway Pressure (PAP) Device parameters

    1 week

  • Leak-Positive Airway Pressure (PAP) Device parameters

    1 week

  • Pressure-Positive Airway Pressure (PAP) Device parameters

    1 week

  • Acoustic Signals

    1 week

Study Arms (1)

Investigational Device

EXPERIMENTAL

Participants will then be asked to take home the investigational device to use at night while they sleep in place of their own device. The participant's therapy and comfort settings will be copied from their own device to the investigational device. Participants will use their own mask with the investigational device for the duration of this study.

Device: Positive Airway Pressure (PAP) Therapy

Interventions

Positive Airway Pressure (PAP) TherapyDEVICE

PAP therapy supplies pressurized air from the flow generator to the upper airway via air tubing and a mask to prevent the repetitive collapse of the upper airway during sleep.

Investigational Device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sleep Data

San Diego, California, 92123, United States

Location

ResMed BELLA VISTA

Sydney, New South Wales, 2153, Australia

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2021

First Posted

February 8, 2021

Study Start

August 12, 2020

Primary Completion

March 5, 2021

Study Completion

March 5, 2021

Last Updated

July 13, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)AU(1)