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Completed

NCT Number: NCT03329352

Evaluation of a Full-Face Mask for the Treatment of Obstructive Sleep Apnea (OSA)

The 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.

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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

Phase

Not applicable

Primary location

North Texas Lung and Sleep Clinic

Fort Worth, Texas, 76109, United States

About this study

The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a full-face 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 full-face mask by a sleep technician for use in-home (Visit 2). The participant then will 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 trial full-face 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 phone call gain feedback or address any issues at months 2 and 4 of the six month extension period. At the end of the six month extension period, the participants will return the trial full-face mask to NTLSC and answer a few questions around their feedback on the mask after using it for six months.

The mask and CPAP (if used from the loan research pool) will be returned to the institution at the conclusion of the trial and participant will return to their usual mask and therapy device for the treatment of Obstructive Sleep Apnea.

Neither the investigators nor the participants will be blinded to the study.

Data from initial 2 week trial is reported here.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • AHI ≥ 5 from diagnostic PSG night
  • Aged 22 and over (FDA defined as adult)
  • Either prescribed APAP, CPAP or Bi-Level PAP for OSA
  • Existing full-face mask users
  • Fluent in spoken and written English

Exclusion criteria

  • Inability to give informed consent
  • Patient intolerant to CPAP therapy
  • Anatomical or physiological conditions making PAP therapy inappropriate
  • Current diagnosis of respiratory disease or CO2 retention
  • Pregnant or think they may be pregnant.

Treatment and study plan

F&P Full-Face Mask

Device

The F&P full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial full-face mask as their primary PAP therapy mask for 6 months after Visit 3.

Primary outcomes

  1. Trial Mask Comfort

    Time frame: 14 ± 5 days in-home

    Determined from questionnaire - Subjective Uses a 5 point Likert Scale (Very Uncomfortable, Uncomfortable, Same as usual, Comfortable, Very Comfortable).

  2. Participant Count of Acceptable Trial Mask Performance - Objective

    Time frame: 14 ± 5 days in-home

    Determined from AHI data, a measure of disease severity, recorded from the PAP device - Objective

  3. Trial Mask Seal Performance - Subjective

    Time frame: 14 ± 5 days in-home

    Determined from questionnaire - Subjective Uses a 5 point Likert Scale

  4. Trial Mask Ease of Cleaning

    Time frame: 14 ± 5 days in-home

    Determined from questionnaires - Subjective

    A single question asked participants to report their ability to clean the mask on a 5 point Likert Scale with scores ranging from very easy, easy, neutral, hard, and very hard.

  5. Trial Mask Ease-of-use

    Time frame: 14 ± 5 days in-home

    Participants experience removing mask from face, determined from questionnaires and a sleep diary - Subjective Uses a 5 point Likert Scale. Also includes, discussion questions around comfort.

Secondary outcomes

  1. Participant Count of Acceptable Mask Leak

    Time frame: 14 ± 5 days in-home

    Data recorded from PAP device reporting amount of air leaking from the mask during PAP therapy. If mask leak was over 60 L/min it was compared to the participants baseline leak values to assess if mask leak with the trial mask was acceptable or not.

  2. Participant Count of Seal Size Determination

    Time frame: 1 day-time appointment (1 hour) Visit 2

    Whether the sizing guide prediction tool used to size participants matched the trial administrators sizing prediction.

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 6, 2017
Registry last updated
Nov 10, 2021

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.

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