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

NCT06972589 | Not Yet Recruiting

• 2 other identifiers: U1111-1322-0270CIA-356
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in respiratory rate

  4 hours

Study Arms (2)

Noninvasive ventilation (CPAP or bilevel) with the investigational mask

EXPERIMENTAL

Device: Investigational Mask

Noninvasive ventilation (CPAP or bilevel) with the conventional mask

ACTIVE COMPARATOR

Device: Conventional mask

Interventions

Investigational Mask DEVICE

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

Noninvasive ventilation (CPAP or bilevel) with the investigational mask

Conventional mask 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (1)

Fisher and Paykel Healthcare Sleep Laboratory

Auckland, 2013, New Zealand

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Obesity Hypoventilation Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• William Good, Medical degree

  Middlemore Hospital, New Zealand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valeria Mereacre, PhD Physiology

CONTACT

02102819036; val.mereacre@fphcare.co.nz

Jessica Fogarin

CONTACT

jess.fogarin@fphcare.co.nz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: May 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)