Skip to main content
OpenTrials
Completed

NCT Number: NCT04011826

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

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.

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

Phase

Not applicable

Primary location

Clayton Sleep Institute

St Louis, Missouri, 63143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Device: Trial nasal mask (F&P)

Device

This trial nasal mask will serve as the participant's primary PAP/BPAP 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 nasal mask as their primary PAP/BPAP therapy mask for 6 months after Visit 3.

Other names: New nasal mask

Primary outcomes

  1. Number of Participants Objective Trial Mask Performance

    Time frame: 14 ± 3 days in home

    Objective measure (determined from efficacy data recorded from the participants PAP/BPAP therapy device.

    Adequate therapy was evaluated by reviewing the Apnea Hypopnea Index (AHI) at baseline to intervention within each individual participants from their PAP therapy device reports. Maintenance of therapy was determined by evaluating the change in AHI. The below data demonstrates how many participants of the analyzed population demonstrated maintenance of therapy after using the new F&P nasal mask.

Secondary outcomes

  1. Number of Participants Trial Mask Overall Simplicity of Use

    Time frame: 14 ± 3 days in home

    Determined from questionnaires - Subjective (uses a 5-point Likert scale measuring ease of use, from very simple, simple, average, challenging, very challenging). Results below represent percentage of respondents for each value.

  2. Number of Participants Subjective Trial Mask Comfort

    Time frame: 14 ± 3 days in home

    Determined from questionnaires - Subjective (uses a 5-point Likert scale measuring comfort from very comfortable, comfortable, average, uncomfortable, very uncomfortable). Participants reported their subject views on mask comfort. Responses to each likert scale option are presented below as percentages.

  3. Number of Participants Overall Trial Mask Satisfaction

    Time frame: 14 ± 3 days in home

    Determined from questionnaires and a sleep diary - Subjective (measuring overall mask satisfaction, includes discussion, questions around overall satisfaction and preference of the new F&P Nasal mask compared to participants' usual mask ).

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 9, 2019
Registry last updated
Dec 1, 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.

Related clinical trials

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