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

NCT ID: NCT02851628

Last Updated: 2018-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-11
• Study Completion Date: 2017-12-20

Brief 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.

Detailed 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.

Conditions

Sleep Disordered Breathing; Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alternative sizing model trial mask

In this arm participants who are randomized to the alternative sizing model based mask will be given the alternative sizing model based mask to use in home for the duration of this arm.

Group Type: EXPERIMENTAL

Alternative sizing model based trial mask

Intervention Type: DEVICE

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 (PFFM)

In this arm, participants who are randomized to the PFFM will be given the PFFM to use in-home for the duration of this arm.

Group Type: ACTIVE_COMPARATOR

Prototype Full Face Mask

Intervention Type: DEVICE

A prototype full face mask with previous clinical trial experience used for the treatment of obstructive sleep apnea using CPAP therapy.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kayan Gonda, BSc

Role: PRINCIPAL_INVESTIGATOR

Sponsor Employee

Locations

Hastings Memorial Hospital

Hastings, Hawkes Bay, New Zealand

Waikato Hospital (Waikato DHB)

Hamilton, Waikato Region, New Zealand

Fisher & Paykel Healthcare

Auckland, , New Zealand

Bowen Hospital

Wellington, , New Zealand

Countries

New Zealand

Other Identifiers

CIA-194

Identifier Type: -

Identifier Source: org_study_id