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Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

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Fisher & Paykel Healthcare

Status

Withdrawn

Conditions

Obstructive Sleep Apnea

Treatments

Device: New nasal pillows mask with PAP therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT04063436
CIA-264

Details and patient eligibility

About

This clinical trial is designed to evaluate the performance, comfort, and usability of a new nasal pillows mask for the treatment of obstructive sleep apnea (OSA) in a home environment.

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Are ≥22 years of age
  • Weigh ≥66 lbs
  • Have been formally diagnosed with OSA by a physician
  • Have an AHI ≥5 on a diagnostic night
  • Have been prescribed PAP therapy to treat OSA by a physician
  • Are an existing nasal pillows mask user
  • Have been using a nasal pillows mask for ≥3 months prior to enrolment into the study
  • Are compliant with PAP therapy for ≥4 hours per night for 70% of nights
  • Are fluent in spoken and written English
  • Possess the capacity to provide informed consent

Exclusion criteria

  • Are intolerant to PAP therapy
  • Possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
  • Are currently diagnosed with respiratory disease or CO2 retention
  • Are pregnant or think they may be pregnant
  • Have an IPAP pressure of >25 cmH2O
  • Persons who use a PAP therapy machine for the delivery of medicines, except O2
  • Use a PAP therapy machine that does not possess data recording capabilities to capture AHI and leak information that is accessible to OSMI

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Experimental
Experimental group
Description:
Participants will be placed in the experimental arm for 14±5 days, during which they will be using the new nasal pillows mask for PAP therapy.
Treatment:
Device: New nasal pillows mask with PAP therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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