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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02894242
Other study ID # CIA-197
Secondary ID
Status Completed
Phase N/A
First received September 5, 2016
Last updated April 2, 2017
Start date September 2016
Est. completion date March 2017

Study information

Verified date April 2017
Source Fisher and Paykel Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.


Description:

A minimum of 20 OSA participants who currently use a nasal pillows mask will be recruited for the trial. Participant will be on the trial for three weeks - first week will be a collection of Positive Airway Pressure (PAP) baseline data on the participant's usual mask. The participant will then use the trial mask in-home for 2 weeks. There is also an option of a two month extension if the participant wish to continue on the trial mask.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date March 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 pillows 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

Study Design


Intervention

Device:
F&P Deimos Nasal Pillows Mask
Investigative Nasal Pillows Mask to be used for OSA therapy

Locations

Country Name City State
New Zealand Fisher and Paykel Healthcare Auckland
New Zealand Hawkes Bay Fallen Soldiers' Memorial Hospital Hastings

Sponsors (1)

Lead Sponsor Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ease of use Subjective questionnaire 2 weeks in home
Primary Acceptability Subjective questionnaire 2 weeks in home
Secondary Objective leak data Obtained from participants' device 2 weeks in home
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