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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-31

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COPD (Chronic Obstructive Pulmonary Disease) Obesity Hypoventilation Syndrome (OHS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Noninvasive ventilation (CPAP or bilevel) with the investigational mask

Group Type EXPERIMENTAL

Investigational Mask

Intervention Type DEVICE

Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy during sleep.

Noninvasive ventilation (CPAP or bilevel) with the conventional mask

Group Type ACTIVE_COMPARATOR

Conventional mask

Intervention Type DEVICE

Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy during sleep.

Interventions

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Investigational Mask

Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy during sleep.

Intervention Type DEVICE

Conventional mask

Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy during sleep.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No