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

This clinical trial is designed to evaluate the performance, comfort, and usability of a new nasal pillows mask for the treatment of obstructive sleep apnea (OSA) in a home environment.

Study Overview

• Status: Withdrawn
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: New nasal pillows mask with PAP therapy

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Dublin, Ohio, United States, 43017
      • Ohio Sleep Medicine Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Are ≥22 years of age
• Weigh ≥66 lbs
• Have been formally diagnosed with OSA by a physician
• Have an AHI ≥5 on a diagnostic night
• Have been prescribed PAP therapy to treat OSA by a physician
• Are an existing nasal pillows mask user
• Have been using a nasal pillows mask for ≥3 months prior to enrolment into the study
• Are compliant with PAP therapy for ≥4 hours per night for 70% of nights
• Are fluent in spoken and written English
• Possess the capacity to provide informed consent

Exclusion Criteria:

• Are intolerant to PAP therapy
• Possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
• Are currently diagnosed with respiratory disease or CO2 retention
• Are pregnant or think they may be pregnant
• Have an IPAP pressure of >25 cmH2O
• Persons who use a PAP therapy machine for the delivery of medicines, except O2
• Use a PAP therapy machine that does not possess data recording capabilities to capture AHI and leak information that is accessible to OSMI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Participants will be placed in the experimental arm for 14±5 days, during which they will be using the new nasal pillows mask for PAP therapy.	Device: New nasal pillows mask with PAP therapy; Participants will be placed in the experimental arm for 14±5 days, during which they will be using the new nasal pillows mask for PAP therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of new nasal pillows mask	The new nasal pillows mask provides adequate PAP therapy for OSA when used in a home environment. This is an objective measure and is determined by the Apnea-Hypopnea Index recorded on PAP therapy machines.	14±5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort of new nasal pillows mask	The new nasal pillows mask is comfortable during PAP therapy for OSA when used in a home environment. This is a subjective measure and is determined by a five-point Likert-type scale as recorded on a questionnaire.	14±5 days
Usability of new nasal pillows mask	The new nasal pillows mask is user-friendly during PAP therapy for OSA when used in a home environment. This is a subjective measure and is determined by a five-point Likert-type scale as recorded on a questionnaire.	14±5 days

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare

Study record dates

Study Major Dates

• Study Start (Anticipated): September 23, 2019
• Primary Completion (Anticipated): October 11, 2019
• Study Completion (Anticipated): October 11, 2019

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (Actual): August 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: CIA-264

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No