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Evaluating the Efficacy of PAP Therapy for Treating OSA in the Home Environment

NCT04744038 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2021-07-13

No results posted yet for this study

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.

Conditions

  • Obstructive Sleep Apnea (OSA)

Interventions

DEVICE

Positive Airway Pressure (PAP) Therapy

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.

Sponsors & Collaborators

  • ResMed

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-12
Primary Completion
2021-03-05
Completion
2021-03-05
FDA Device
Yes

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04744038 on ClinicalTrials.gov