Physiological Study to Compare Noninvasive Ventilation (NIV) Masks

Noninvasive ventilation (NIV) is an established therapy that delivers positive pressure to the upper airways to provide respiratory support. Two types of NIV can be delivered; continuous positive airway pressure (CPAP) at one continuous pressure and bilevel NIV at two pressures for inhalation and exhalation.

This investigation is designed to physiologically evaluate the performance of a NIV mask, Mask A, compared to a standard NIV mask, Mask B on CPAP therapy.

People with sleep disordered breathing who have chronic hypercapnia, and are already receiving nocturnal CPAP will be recruited. They will receive one night's CPAP therapy on Mask A and 1 night on Mask B in random order. Physiological parameters will be recorded.

Parameters will be recorded during three baselines at the beginning of each evening and throughout the night when participants are asleep. The three baselines are:

1. participant awake with normal breathing (not on CPAP),
2. participant awake and on CPAP, and
3. participant asleep on CPAP in REM-sleep (rapid eye movement sleep).

Study Overview

• Status: Terminated
• Conditions: Sleep-disordered Breathing; Hypercapnia
• Intervention / Treatment: Device: CPAP with Mask A; Device: CPAP with Mask B

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand, 1051
    • New Zealand Respiratory and Sleep Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Already using overnight CPAP and tolerating the therapy well (over 4 hours use/night)
• Hypercapnia: venous bicarbonate of 30 milliequivalents of solute per liter (Eq/L) or more, OR transcutaneous carbon dioxide (TcCO2) of 50 millimeters of mercury (mmHg) of more.
• Provide written informed consent
• Already use a full (oronasal) face mask for CPAP
• Willing to have a venous blood sample taken during the pre-screening visit.

Exclusion Criteria:

• Presence of sleep apnea on CPAP:

  • Subjects excluded if they have an apnea-hypopnea index (AHI) of more than 20, or
  • If the AHI has not already decreased by 50 percent or more from pre-CPAP to with CPAP.
• Forced expiratory volume in 1 second (FEV1) of less than 40 percent of predicted.

• Forced expiratory volume in 1 second divided by forced vital capacity (FEV1/FVC) less than fifty percent of predicted, at the screening visit.

  • Have poorly controlled asthma or changing asthma symptoms.
  • Nasal obstruction
  • Do not fit Mask A or Mask B
  • Agitation or psychological illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mask A; Overnight CPAP using the participant's usual pressure settings and using Mask A. One night only.	Device: CPAP with Mask A; CPAP mask
Active Comparator: Mask B; Overnight CPAP using the participant's usual pressure settings and using Mask B. One night only.	Device: CPAP with Mask B; CPAP mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transcutaneous carbon dioxide	The change in transcutaneous carbon dioxide from the 3 different baselines to the transcutaneous carbon dioxide during non-REM sleep on CPAP on the same study night. Three different values will be determined for each mask.	1 day (From baseline to the end of the study night)

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Andy Veale, Dr, New Zealand Respiratory and Sleep Insitute

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2021
• Primary Completion (Actual): October 14, 2022
• Study Completion (Actual): July 5, 2023

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Hypercapnia
• Other Study ID Numbers: CIA-279; U1111-1259-4797 (Registry Identifier: WHO Universal trial number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No