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NCT06972589Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 15 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
20 (estimated)
First submitted
7 May 2025
Start date
May 2025
Primary completion date
Apr 2026
Lead sponsor
Fisher and Paykel Healthcare
Diseases
Obesity, COPD
NCT number
NCT06972589

What you commit to

  • Study type: Interventional
  • Planned participants: 20
  • From May 2025 to the primary completion date, Apr 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Allergic to adhesive of the sensors

Other

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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fisher and Paykel Healthcare Sleep Laboratory
Coordinator of this site? Confirm its status
AucklandNew ZealandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.