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The Evaluation of a Novel Nasal Mask for the Treatment of Obstructive Sleep Apnea

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Nasal CPAP mask
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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult (18+ years of age)
  • Able to give consent
  • Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
  • Prescribed PAP for OSA
  • Existing nasal mask user

Exclusion Criteria:

  • Inability to give consent
  • Patients who are in a coma or a decreased level of consciousness
  • Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
  • Commercial drivers who are investigated by New Zealand Transport Agency
  • Current diagnosis of carbon dioxide (CO2) retention
  • Pregnant or may think they are pregnant

Sites / Locations

  • Hastings Memorial Hospital
  • WellSleep

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trial nasal Continuous Positive Airway Pressure (CPAP) mask

Arm Description

Trial nasal CPAP mask

Outcomes

Primary Outcome Measures

Ease of use
Subjective Questionnaire
Acceptability
Subjective Questionnaire

Secondary Outcome Measures

Objective leak data
Data obtained from participant's device - Objective

Full Information

First Posted
January 22, 2018
Last Updated
March 20, 2018
Sponsor
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT03413098
Brief Title
The Evaluation of a Novel Nasal Mask for the Treatment of Obstructive Sleep Apnea
Official Title
The Evaluation of a Novel Nasal Mask for the Treatment of Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
March 9, 2018 (Actual)
Study Completion Date
March 9, 2018 (Actual)

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
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F&P trial nasal mask amongst Obstructive Sleep Apnea (OSA) patients.
Detailed Description
Visit 1 will involve the participants consented in to the trial. Visit 2 will involve the participants being fitted with the F&P trial nasal mask for use in-home. The participant will then come in to return the mask (Visit Three) and have a final interview, this ensures the maximum time participants will be exposed to the trial mask in home will be 14 ± 4 days from visit two. The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all patients within 1 week of the beginning of the study.

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
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trial nasal Continuous Positive Airway Pressure (CPAP) mask
Arm Type
Experimental
Arm Description
Trial nasal CPAP mask
Intervention Type
Device
Intervention Name(s)
Nasal CPAP mask
Intervention Description
Investigative Nasal Mask to be used for OSA therapy
Primary Outcome Measure Information:
Title
Ease of use
Description
Subjective Questionnaire
Time Frame
2 weeks
Title
Acceptability
Description
Subjective Questionnaire
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Objective leak data
Description
Data obtained from participant's device - Objective
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult (18+ years of age) Able to give consent Apnea hypopnea Index (AHI)≥ 5 on diagnostic night Prescribed PAP for OSA Existing nasal mask user Exclusion Criteria: Inability to give consent Patients who are in a coma or a decreased level of consciousness Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure) Commercial drivers who are investigated by New Zealand Transport Agency Current diagnosis of carbon dioxide (CO2) retention Pregnant or may think they are pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Gunson
Organizational Affiliation
Sponsor Employee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hastings Memorial Hospital
City
Hastings
Country
New Zealand
Facility Name
WellSleep
City
Wellington
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

The Evaluation of a Novel Nasal Mask for the Treatment of Obstructive Sleep Apnea

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