The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea

Fisher and Paykel Healthcare38 enrolled

Overview

The investigation is a prospective, randomized, single blinded, crossover study. The investigation is designed to evaluate the performance, comfort and ease of use of the F\&P Trial Full Face Mask Seal amongst Obstructive Sleep Apnea (OSA) participants. A total number of 40-45 OSA participants will be recruited for the trial by the investigation site

This study will involve three visits to the investigation site. During visit one participants will be randomized to, fitted with and issued with the first trial mask seal for use in- home for 7 ±4 days. The participants will then come in to return the mask seal and be fitted and issued with the second trial seal for use in home for 7±4 days. Visit Three will involve the participants returning the second trial seal and providing feedback.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

Toffee full face mask with 'Improved Seal'DEVICE

Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.

Toffee full face mask with 'Normal Seal'DEVICE

Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult (22+ years of age) * Able to give informed consent * Apnea hypopnea Index (AHI) ≥ 5 on diagnostic night * Either prescribed Automatic positive airway pressure (APAP), Continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (PAP) for OSA * Fluent in spoken and written English * Existing F\&P full face mask user Exclusion Criteria: * Inability to give informed consent * Participant intolerant to PAP * Anatomical or physiological conditions making PAP therapy inappropriate * Current diagnosis of respiratory disease or carbon Dioxide (CO2) retention * Pregnant or may think they are pregnant.

Locations (1)

Clinical Trials of Florida

Miami, Florida, United States

Outcomes

Primary Outcomes

Trial Mask Seal Comfort

Overall seal comfort determined from questionnaires- Subjective

Time frame: 7 ± 4 days in-home

Trial Mask Seal Acceptability

Preference for trial mask determined from questionnaires at the end of the trial - Subjective

Time frame: 14 ± 4 days in-home

Secondary Outcomes

Trial Mask Seal Treatment Performance - Objective

Objective Apnea Hypopnea Index (AHI) data recorded from Positive airway pressure (PAP) device, compared to baseline AHI data

Time frame: 7 ± 4 days in-home

Trial Mask Seal Usability

Usability interview during first visit- Subjective

Time frame: 1 hour day-time appointment

Trial Mask Seal Treatment Performance- Subjective

Seal performance determined from questionnaires - Subjective

Time frame: 7 ± 4 days in-home

Data from ClinicalTrials.gov

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