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Completed

NCT Number: NCT03142438

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

This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F&P trial full face and nasal mask amongst Obstructive Sleep Apnea (OSA) patients. Up to 70 OSA patients will be recruited from the North Texas Lung and Sleep Clinic (NTLSC) database

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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

Visit 1 will involve the participants being fitted with the F&P trial full face or nasal mask for use in-home.

The participant will then come in to return the mask (Visit Two) and have a final interview, this ensures the maximum time participants will be exposed to the trial mask in home will be 14 ± 4 days from visit one.

The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all patients within three weeks of the beginning of the study.

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 oronasal and nasal 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

F&P Seal Improvement Project

Device

Participants will be placed on this arm for a total 14 ± 4 days from Visit 1. Participants will be using the trial full face or nasal mask during this treatment arm.

Primary outcomes

  1. Number of Participants Subjective Usability Reporting

    Time frame: 14 ± 4 days in-Home

    Usability reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea

  2. Number or Participants Comparative Subjective Reported Comfort

    Time frame: 14 ± 4 days in-Home

    Comfort reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea compared to usual

Secondary outcomes

  1. Objective Performance Reporting

    Time frame: 14 ± 4 days in-Home

    Objective Apnea-Hypopnea Index (AHI) data recorded from the positive airway pressure (PAP) device to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea

  2. Number of Participants Reported Mask Acceptability

    Time frame: 14 ± 4 days in-Home

    Acceptability reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea

  3. Number of Participants Subjective Comfort Reporting

    Time frame: 14 ± 4 days in-Home

    Comfort reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea

  4. Number or Participants Subjective Reporting of Seal Performance

    Time frame: 14 ± 4 days in-Home

    Seal performance reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Collaborators

  • North Texas Lung & Sleep Clinic

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 5, 2017
Registry last updated
Jul 14, 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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