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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02851628
Other study ID # CIA-194
Secondary ID
Status Completed
Phase N/A
First received July 28, 2016
Last updated April 16, 2018
Start date September 11, 2017
Est. completion date December 20, 2017

Study information

Verified date April 2018
Source Fisher and Paykel Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigation is a prospective non-blinded and semi-randomized clinical investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the Prototype Full Face Mask (PFFM) mask.


Description:

The investigation is a prospective non-blinded and semi-randomized investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the Prototype Full Face Mask (PFFM) mask. A cohort of up to 38 pre-determined current nasal and full face mask users will be recruited by Fisher & Paykel Healthcare in Auckland New Zealand, Waikato DHB in Hamilton New Zealand, Hawkes Bay DHB in Hastings New Zealand and WellSleep Centre in Wellington New Zealand.

The study will involve baseline (visit one) gathering the participants' prescribed PAP therapy pressure and their usual mask (to have up-to-date records). The next visit (visit 2) 7 ± 4 days after visit 1, the participants will be fit the Prototype Full Face Mask (PFFM) mask or the alternative sizing based trial mask. At visit 3, which will be after 7 ± 4 days from visit 2, the participants will be crossed over to the mask. At visit 4, 7 ± 4 days after visit 3, all masks and devices will be collected from the participants.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 20, 2017
Est. primary completion date November 3, 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 a Continuous Positive Airway Pressure (CPAP) device after successful OSA diagnosis

- Existing nasal or full face 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 APAP therapy inappropriate (e.g. unconsolidated facial structure)

- Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)

- Current diagnosis of CO2 retention

- Pregnant or may think they are pregnant.

Study Design


Intervention

Device:
Alternative sizing model based trial mask
A trial full face mask to be used for this trial for the treatment of obstructive sleep apnea using CPAP therapy.
Prototype Full Face Mask
A prototype full face mask with previous clinical trial experience used for the treatment of obstructive sleep apnea using CPAP therapy.

Locations

Country Name City State
New Zealand Fisher & Paykel Healthcare Auckland
New Zealand Waikato Hospital (Waikato DHB) Hamilton Waikato
New Zealand Hastings Memorial Hospital Hastings Hawkes Bay
New Zealand Bowen Hospital Wellington

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 Seal Comfort Obtained from subjective questionnaire Up to 3 weeks in-home
Primary Subjective Seal Leak Obtained from subjective questionnaire Up to 3 weeks in-home
Primary Objective Seal Leak Measured by device data Up to 3 weeks in-home
Secondary Objective correct mask selection Measured by device leak data Up to 3 weeks in-home
Secondary Subjective correct mask selection Measured by subjective questionnaire Up to 3 weeks in-home
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