Sleep-disordered BreathingNCT04926805
Physiological Study to Compare Noninvasive Ventilation (NIV) Masks
A study testing CPAP with Mask A and CPAP with Mask B in people with Sleep-disordered Breathing and Hypercapnia, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sleep-disordered Breathing, Hypercapnia
- What is being tested?
- CPAP with Mask A and CPAP with Mask B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNew Zealand
- Study dates
- 7 Jul 2021to 5 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Nasal obstruction
- Do not fit Mask A or Mask B
- Agitation or psychological illness
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
New Zealand Respiratory and Sleep Institute
Auckland, 1051
About this study
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.
Read more
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).
- Conditions
- Sleep-disordered Breathing, Hypercapnia
- Being tested
- CPAP with Mask A, CPAP with Mask B
- Medical subject headings
- Sleep Apnea Syndromes, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP with Mask ADevice
CPAP mask
CPAP with Mask BDevice
CPAP mask
| Study group | Role | What they receive |
|---|---|---|
| Mask A | Experimental | Overnight CPAP using the participant's usual pressure settings and using Mask A. One night only. Receives: Device: CPAP with Mask A |
| Mask B | Active comparator | Overnight CPAP using the participant's usual pressure settings and using Mask B. One night only. Receives: Device: CPAP with Mask B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day (From baseline to the end of the study night)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start7 Jul 2021
- Primary completion14 Oct 2022
- Study completion5 Jul 2023
Why it stopped: Extremely slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-disordered BreathingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andy Veale, Dr, Principal investigator, New Zealand Respiratory and Sleep Insitute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926805
- Sponsor's protocol ID
- CIA-279
- Other IDs
- U1111-1259-4797
- Status last verified
- Jul 2023
- First submitted
- 2 Jun 2021
- Last updated
- 12 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Study to Compare Noninvasive Ventilation (NIV) Masks
- ClinicalTrials.gov ID
- NCT04926805
- Acronym / sponsor ID
- CIA-279
- Conditions
- Sleep-disordered Breathing, Hypercapnia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Extremely slow recruitment
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 14 Oct 2022 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 15 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mask A | Experimental | Device: CPAP with Mask AOvernight CPAP using the participant's usual pressure settings and using Mask A. One night only. |
| Mask B | Active comparator | Device: CPAP with Mask BOvernight CPAP using the participant's usual pressure settings and using Mask B. One night only. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- Presence of sleep apnea on 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP with Mask ACPAP mask | Device | Mask A |
| CPAP with Mask BCPAP mask | Device | Mask B |
Primary outcome
Transcutaneous carbon dioxide
Time frame: 1 day (From baseline to the end of the study night)
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.
Results and safety
The study was stopped early (reason given: Extremely slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andy Veale, Dr principal investigator
New Zealand Respiratory and Sleep Insitute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP with Mask A and CPAP with Mask B in people with Sleep-disordered Breathing and Hypercapnia, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Extremely slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcutaneous carbon dioxide (time frame: 1 day (From baseline to the end of the study night)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.