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

NCT04011826 | Completed Results DMC FDA Device

• 1 other identifier: CIA-262
• Study Type: interventional
• Target: 45
• 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 (1)

• Number of Participants Objective Trial Mask Performance

  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.

  14 ± 3 days in home

Secondary Outcomes (3)

• Number of Participants Trial Mask Overall Simplicity of Use

  14 ± 3 days in home

• Number of Participants Subjective Trial Mask Comfort

  14 ± 3 days in home

• Number of Participants Overall Trial Mask Satisfaction

  14 ± 3 days in home

Study Arms (1)

Experimental: Experimental trial nasal mask

EXPERIMENTAL

Experimental trial nasal mask: Participants will be placed on this arm for a total of 14±3 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm. Participants on the extension will use this trial mask for a further six months after Visit 3.

Device: Device: Trial nasal mask (F&P)

Interventions

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.

Also known as: New nasal mask

Experimental: Experimental trial nasal mask

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (1)

Clayton Sleep Institute

St Louis, Missouri, 63143, 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: Clinical Research Scientist
• Organization: Fisher and Paykel Healthcare

CPAP.trial@fphcare.co.nz

+64 09 574 0123

Study Officials

• Mark Muehlbach

  Clinical Director

  PRINCIPAL INVESTIGATOR

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: July 2, 2019
• First Posted: July 9, 2019
• Study Start: August 5, 2019
• Primary Completion: April 30, 2020
• Study Completion: August 30, 2020
• Last Updated: December 1, 2021
• Results First Posted: July 6, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)