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

Primary Purpose

Obstructive Sleep Apnea

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
New nasal pillows mask with PAP therapy
Sponsored by
Fisher and Paykel Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ohio Sleep Medicine Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm 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.

Outcomes

Primary Outcome Measures

Performance of new nasal pillows mask
The new nasal pillows mask provides adequate PAP therapy for OSA when used in a home environment. This is an objective measure and is determined by the Apnea-Hypopnea Index recorded on PAP therapy machines.

Secondary Outcome Measures

Comfort of new nasal pillows mask
The new nasal pillows mask is comfortable during PAP therapy for OSA when used in a home environment. This is a subjective measure and is determined by a five-point Likert-type scale as recorded on a questionnaire.
Usability of new nasal pillows mask
The new nasal pillows mask is user-friendly during PAP therapy for OSA when used in a home environment. This is a subjective measure and is determined by a five-point Likert-type scale as recorded on a questionnaire.

Full Information

First Posted
August 13, 2019
Last Updated
March 19, 2020
Sponsor
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT04063436
Brief Title
Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
Official Title
Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Clinical trial was cancelled
Study Start Date
September 23, 2019 (Anticipated)
Primary Completion Date
October 11, 2019 (Anticipated)
Study Completion Date
October 11, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
After the baseline period, all participants will be trialed on the same new nasal pillows mask.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
New nasal pillows mask with PAP therapy
Intervention 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.
Primary Outcome Measure Information:
Title
Performance of new nasal pillows mask
Description
The new nasal pillows mask provides adequate PAP therapy for OSA when used in a home environment. This is an objective measure and is determined by the Apnea-Hypopnea Index recorded on PAP therapy machines.
Time Frame
14±5 days
Secondary Outcome Measure Information:
Title
Comfort of new nasal pillows mask
Description
The new nasal pillows mask is comfortable during PAP therapy for OSA when used in a home environment. This is a subjective measure and is determined by a five-point Likert-type scale as recorded on a questionnaire.
Time Frame
14±5 days
Title
Usability of new nasal pillows mask
Description
The new nasal pillows mask is user-friendly during PAP therapy for OSA when used in a home environment. This is a subjective measure and is determined by a five-point Likert-type scale as recorded on a questionnaire.
Time Frame
14±5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ohio Sleep Medicine Institute
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43017
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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