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NCT Number: NCT06972589

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fisher and Paykel Healthcare Sleep Laboratory

Auckland, 2013, New Zealand

Location contact

Jessica Fogarin

CONTACT

[email protected]

7327

Valeria Mereacre, PhD Physiology

SUB_INVESTIGATOR

William Good, Medical degree

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Investigational Mask

Device

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

Conventional mask

Device

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

Primary outcomes

  1. Change in respiratory rate

    Time frame: 4 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Fogarin

CONTACT

[email protected]

Valeria Mereacre, PhD Physiology

CONTACT

[email protected]

02102819036

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 15, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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