The Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep Apnea

Fisher & Paykel Healthcare

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Device: Trial nasal mask (F&P)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04011826

CIA-262

Details and patient eligibility

About

This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.

Full description

The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a nasal, sub-nasal or pillows mask will be recruited.

The study will involve a baseline (Visit 1) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial nasal mask by a mask fitting expert for use in-home (Visit 2). There will be a follow up phone call to gain feedback or address any issues after 3±1 days. The participant will then come in to return the mask (Visit 3) and give feedback on their experience using the mask in home in the form of a structured interview during Visit 3. If the participants prefer the trail nasal mask they will be asked if they would like to continue using the trial mask for a further six months in-home. There will be a follow up monthly phone call to gain feedback or address any issues during the extension. At the end of the six month extension period, the participants will return the trial nasal mask to the institution and give feedback on their experience using the mask in home in the form of a self-administered questionnaire. Participants will revert to their usual masks thereafter. Neither the participants nor the investigators will be blinded to the study.

Enrollment: 45 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of OSA by Physician
• ≥ 22 years of age
• ≥ 66 lbs
• Prescribed PAP or BPAP therapy for OSA
• Existing nasal, sub-nasal and pillows mask users
• Fluent in written and spoken English

Exclusion criteria

• Inability to give informed consent
• Pregnant or think they may be pregnant
• PAP Intolerant
• Anatomical or Physiological Conditions that make PAP inappropriate
• IPAP pressure of ≤25cmH20.
• PAP/BPAP therapy device without data recording capabilities
• Using a PAP/BPAP therapy device for the delivery any medication with the exception of oxygen

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Experimental: Experimental trial nasal mask

Experimental group

Description:

Experimental trial nasal mask: Participants will be placed on this arm for a total of 14±3 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm. Participants on the extension will use this trial mask for a further six months after Visit 3.

Treatment:

Device: Device: Trial nasal mask (F&P)