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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03329352
• Other study ID #: CIA-227
• Status: Completed
• Phase: N/A
• Start date: November 3, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: October 2021
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• F&P Full-Face Mask
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.

Locations

Country	Name	City	State
United States	North Texas Lung and Sleep Clinic	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trial Mask Comfort	Determined from questionnaire - Subjective Uses a 5 point Likert Scale (Very Uncomfortable, Uncomfortable, Same as usual, Comfortable, Very Comfortable).	14 ± 5 days in-home
Primary	Participant Count of Acceptable Trial Mask Performance - Objective	Determined from AHI data, a measure of disease severity, recorded from the PAP device - Objective	14 ± 5 days in-home
Primary	Trial Mask Seal Performance - Subjective	Determined from questionnaire - Subjective Uses a 5 point Likert Scale	14 ± 5 days in-home
Primary	Trial Mask Ease of Cleaning	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.	14 ± 5 days in-home
Primary	Trial Mask Ease-of-use	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.	14 ± 5 days in-home
Secondary	Participant Count of Acceptable Mask Leak	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.	14 ± 5 days in-home
Secondary	Participant Count of Seal Size Determination	Whether the sizing guide prediction tool used to size participants matched the trial administrators sizing prediction.	1 day-time appointment (1 hour) Visit 2