Investigative Headgear With Nasal Pillows Continuous Positive Airway Pressure (CPAP) Mask

Investigative Headgear With Nasal Pillows CPAP Mask

This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the headgear with a CPAP mask for a duration of 6 months.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Investigative Headgear with CPAP mask

Detailed Description

20 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level Positive airway pressure (PAP) for the treatment of their Obstructive Sleep Apnea (OSA). These include current CPAP mask users.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand, 2013
    • Fisher & Paykel Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• AHI≥5 from the diagnostic night
• ≥18 years of age
• Prescribed CPAP or Bi-level therapy for OSA
• Existing F&P Pilairo Q, Eson, Simplus mask users

Exclusion Criteria:

• Inability to give informed consent
• Patient intolerant to CPAP
• Anatomical or physiological conditions making CPAP therapy inappropriate
• History of respiratory disease or carbon dioxide (CO2) retention
• Pregnant or think they may be pregnant
• Investigated by Land Transport Safety Authority

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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: Headgear; Investigative Headgear with CPAP mask	Device: Investigative Headgear with CPAP mask; Investigative Headgear with CPAP mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability of the headgear using a Questionnaire	Assessment of headgear properties on a monthly basis via custom questionnaire via phone call	Monthly over a period of 6 months
Durability of the headgear by testing	Assessment of headgear properties on a monthly basis, and changes to the headgear	Monthly over a period of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance in regards to leak of the headgear	Objective Leak Data (L/min) from the device download	Monthly over a period of 6 months
Performance in regards to comfort of the headgear	Custom Questionnaire	Monthly over a period of 6 months

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Sarah Gunson, BSc, Clinical Research Associate

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: October 11, 2016
• First Submitted That Met QC Criteria: October 20, 2016
• First Posted (Estimate): October 24, 2016

Study Record Updates

• Last Update Posted (Actual): March 21, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: CIA 150