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

Fisher & Paykel Healthcare

Status: Not yet enrolling

Conditions: COPD (Chronic Obstructive Pulmonary Disease); Obesity Hypoventilation Syndrome (OHS)

Treatments: Device: Investigational Mask; Device: Conventional mask

Study type: Interventional

Funder types: Industry

Identifiers

NCT06972589

U1111-1322-0270

CIA-356 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Noninvasive ventilation (CPAP or bilevel) with the investigational mask

Experimental group

Treatment:

Device: Investigational Mask

Noninvasive ventilation (CPAP or bilevel) with the conventional mask

Active Comparator group

Treatment:

Device: Conventional mask