A Development Study to Evaluate a Nasal Mask for the Treatment of Obstructive Sleep Apnea

NCT03124069 | Completed Results DMC FDA Device

• 1 other identifier: CIA-211
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (5)

• Number of Participants Reporting Comfort Compared to Their Usual Mask.

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

  14 ± 5 days In-Home

• Number of Participants PAP Device Performance Reporting

  Determined from data recorded from the PAP device to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea

  14 ± 5 days In-Home

• Number of Participants Subjective Performance Rating of the Nasal Mask

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

  14 ± 5 days In-Home

• Number of Participants Subjective Reporting of Nasal Mask Usability

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

  During Visit Two - 20 minutes

• Number of Participants Subjective Recording of Ease of Nasal Mask Use.

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

  14 ± 5 days In-Home

Secondary Outcomes (2)

• Number of Participants Leak Compared to Usual Mask

  14 ± 5 days In-Home

• Number of Participants With Correct Nasal Mask Size Determination

  1 day-time appointment (1 hour)

Study Arms (1)

F&P Saturn

EXPERIMENTAL

Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.

Device: F&P Saturn

Interventions

F&P Saturn DEVICE

Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.

F&P Saturn

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 nasal or nasal pillows mask users (preferable 70%:30% split)
• Fluent in spoken and written English

You may not qualify if:

• 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

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (1)

Clinical Trials of Florida

South Miami, Florida, 33186, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Hanie Yee
• Organization: Fisher & Paykel Healthcare

Hanie.Yee@fphcare.co.nz

+64 9 574 0123

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: After a period of baseline, all enrolled participants will be put on the same trial mask.

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 21, 2017
• Study Start: April 24, 2017
• Primary Completion: May 26, 2017
• Study Completion: September 30, 2017
• Last Updated: July 14, 2021
• Results First Posted: July 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)