The Effect of Mask Design on Ventilation Parameters in COPD and OHS Patients on Long-term Home Non-invasive Ventilation. An Experimental Study.

May 7, 2025 updated by: Fisher and Paykel Healthcare
Chronic obstructive pulmonary disease (COPD) and obesity hypoventilation syndrome (OHS) are respiratory conditions that disrupt normal breathing. Positive airway pressure, specifically Non-Invasive Ventilation (NIV) delivers positive pressures via an interface such as a face mask and has been shown to improve breathing and reduce symptoms in patients with these conditions. Regular use of NIV can lead to better symptom management, improved quality of life, and reduced use of healthcare resources. However, poor performance of the NIV mask and poor comfort can make NIV therapy harder to tolerate. This study will assess if a new mask helps to improve the breathing of people on NIV and normalize blood gases.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants are moved to the sleep laboratory for the night where they are provided with beds.

  • The participants are put on their prescribed airway pressure support with the first randomized mask.
  • After at least 60 minutes of recording, participants are awakened to switch back to the second mask. They are then allowed to sleep uninterrupted for the rest of the night.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age over 18 years
  • Prescribed nocturnal NIV for COPD or OHS
  • Able to complete an overnight sleep study
  • Comfortable to sleep on a standard double bed
  • Capacity to complete informed consent

Exclusion Criteria:

  • Uncontrolled sleep apnea (Apnea-hypopnea index (AHI) over 15 events/hour off personal NIV device data)
  • Prescribed IPAP above 25 cmH2O
  • Allergic to adhesive of the sensors
  • Self-reported cold/flu symptoms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Noninvasive ventilation (CPAP or bilevel) with the investigational mask
Device: Investigational Mask
Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy during sleep.
Active Comparator: Noninvasive ventilation (CPAP or bilevel) with the conventional mask
Device: Conventional mask
Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy during sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in respiratory rate
Time Frame: 4 hours
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fisher and Paykel Healthcare

Investigators

  • Principal Investigator: William Good, Medical degree, Middlemore Hospital, New Zealand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

May 7, 2025

First Submitted That Met QC Criteria

May 7, 2025

First Posted (Actual)

May 15, 2025

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 7, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1322-0270
  • CIA-356 (Other Identifier: Fisher and Paykel Healthcare)

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

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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