The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full Face Masks in the Treatment of OSA in Terms of Performance and Comfort

Obstructive Sleep Apnea Clinical Trial

Official title:

The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full-face Masks in the Treatment of OSA in Terms of Performance and Comfort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02851628
• Other study ID #: CIA-194
• 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
• 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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive
• Sleep Disordered Breathing

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