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CompletedNCT03413098Updated Mar 22, 2018

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

An interventional study of Nasal CPAP mask in Obstructive Sleep Apnea, sponsored by Fisher and Paykel Healthcare. Completed at 2 sites in New Zealand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-22.

Sponsored by Fisher and Paykel Healthcare · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obstructive Sleep Apnea
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Trial nasal Continuous Positive Airway Pressure (CPAP) mask

    Trial nasal CPAP mask

    Device: Nasal CPAP mask

Interventions

  • DeviceNasal CPAP mask

    Investigative Nasal Mask to be used for OSA therapy

05

What researchers measure

Primary outcomes

  1. Ease of use

    Subjective Questionnaire

    Time frame: 2 weeks

  2. Acceptability

    Subjective Questionnaire

    Time frame: 2 weeks

Secondary outcomes

  1. Objective leak data

    Data obtained from participant's device - Objective

    Time frame: 2 weeks

06

Study locations

2 sites
  • Hastings Memorial Hospital
    Hastings, New Zealand
  • WellSleep
    Wellington, New Zealand
07

Registry details

Key details

Study ID
NCT03413098
Lead sponsor
Fisher and Paykel Healthcare
Responsible party
Sponsor
First posted
Jan 29, 2018
Start date
Feb 12, 2018
Primary completion
Mar 9, 2018
Completion
Mar 9, 2018
Last update
Mar 22, 2018

Study contacts

Sarah Gunson
principal investigator · Sponsor Employee

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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