Skip to main content
OpenTrials
Completed

NCT Number: NCT03230877

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Primary location

Clinical Trials of Florida

Miami, Florida, 33186, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Trial Mask Seal Comfort

    Time frame: 7 ± 4 days in-home

    Overall seal comfort determined from questionnaires- Subjective

  2. Trial Mask Seal Acceptability

    Time frame: 14 ± 4 days in-home

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

Secondary outcomes

  1. Trial Mask Seal Treatment Performance - Objective

    Time frame: 7 ± 4 days in-home

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

  2. Trial Mask Seal Usability

    Time frame: 1 hour day-time appointment

    Usability interview during first visit- Subjective

  3. Trial Mask Seal Treatment Performance- Subjective

    Time frame: 7 ± 4 days in-home

    Seal performance determined from questionnaires - Subjective

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 27, 2017
Registry last updated
Sep 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.