Investigative Headgear With Nasal Pillows Continuous Positive Airway Pressure (CPAP) Mask

Fisher & Paykel Healthcare

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Investigative Headgear with CPAP mask

Study type: Interventional

Funder types: Industry

Identifiers

NCT02942446

CIA 150

Details and patient eligibility

About

This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the headgear with a CPAP mask for a duration of 6 months.

Full description

20 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level Positive airway pressure (PAP) for the treatment of their Obstructive Sleep Apnea (OSA). These include current CPAP mask users.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• AHI≥5 from the diagnostic night
• ≥18 years of age
• Prescribed CPAP or Bi-level therapy for OSA
• Existing F&P Pilairo Q, Eson, Simplus mask users

Exclusion criteria

• Inability to give informed consent
• Patient intolerant to CPAP
• Anatomical or physiological conditions making CPAP therapy inappropriate
• History of respiratory disease or carbon dioxide (CO2) retention
• Pregnant or think they may be pregnant
• Investigated by Land Transport Safety Authority

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Headgear

Experimental group

Description:

Investigative Headgear with CPAP mask

Treatment:

Device: Investigative Headgear with CPAP mask