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Physiological Study to Compare Noninvasive Ventilation (NIV) Masks

Primary Purpose

Sleep-disordered Breathing, Hypercapnia

Status
Terminated
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
CPAP with Mask A
CPAP with Mask B
Sponsored by
Fisher and Paykel Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep-disordered Breathing

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New Zealand Respiratory and Sleep Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mask A

Mask B

Arm Description

Overnight CPAP using the participant's usual pressure settings and using Mask A. One night only.

Overnight CPAP using the participant's usual pressure settings and using Mask B. One night only.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 2, 2021
Last Updated
July 10, 2023
Sponsor
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT04926805
Brief Title
Physiological Study to Compare Noninvasive Ventilation (NIV) Masks
Official Title
Physiological Study to Compare Noninvasive Ventilation (NIV) Masks
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Extremely slow recruitment
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
October 14, 2022 (Actual)
Study Completion Date
July 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare

4. Oversight

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

5. Study Description

Brief Summary
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: participant awake with normal breathing (not on CPAP), participant awake and on CPAP, and participant asleep on CPAP in REM-sleep (rapid eye movement sleep).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep-disordered Breathing, Hypercapnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mask A
Arm Type
Experimental
Arm Description
Overnight CPAP using the participant's usual pressure settings and using Mask A. One night only.
Arm Title
Mask B
Arm Type
Active Comparator
Arm Description
Overnight CPAP using the participant's usual pressure settings and using Mask B. One night only.
Intervention Type
Device
Intervention Name(s)
CPAP with Mask A
Intervention Description
CPAP mask
Intervention Type
Device
Intervention Name(s)
CPAP with Mask B
Intervention Description
CPAP mask
Primary Outcome Measure Information:
Title
Transcutaneous carbon dioxide
Description
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.
Time Frame
1 day (From baseline to the end of the study night)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andy Veale, Dr
Organizational Affiliation
New Zealand Respiratory and Sleep Insitute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Zealand Respiratory and Sleep Institute
City
Auckland
ZIP/Postal Code
1051
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Physiological Study to Compare Noninvasive Ventilation (NIV) Masks

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