Physiological Study to Compare Noninvasive Ventilation (N... | NCT04926805

Studies
Physiological Study to Compare Noninvasive Ventilation (NIV) Masks

NCT04926805

Sponsor

Fisher and Paykel Healthcare

Status

Terminated

Last Update Posted

Jul 12, 2023Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Sleep-disordered Breathing
Hypercapnia

Interventions

CPAP with Mask A
CPAP with Mask B

Countries

New Zealand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1259-4797	Registry Identifier	WHO Universal trial number

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Extremely slow recruitment

Expanded Access Info

Start Date

Jul 7, 2021Actual

Primary Completion Date

Oct 14, 2022Actual

Completion Date

Jul 5, 2023Actual

First Submitted Date

Jun 2, 2021

First Submission Date that Met QC Criteria

Jun 14, 2021

First Posted Date

Jun 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2023

Last Update Posted Date

Jul 12, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mask A	Experimental	Overnight CPAP using the participant's usual pressure settings and using Mask A. One night only.	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.	Device: CPAP with Mask B

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CPAP with Mask A	Device	CPAP mask	Mask A
CPAP with Mask B

Outcomes Module

Primary Outcomes

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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andy Veale, Dr	New Zealand Respiratory and Sleep Insitute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New Zealand Respiratory and Sleep Institute		Auckland		1051	New Zealand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes
D006935	Hypercapnia

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D045422	Continuous Positive Airway Pressure

Ancestor Terms

ID	Term
D011175	Positive-Pressure Respiration
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided