Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT04926805
Status:
TERMINATED
Last Update Posted:
2023-07-12
First Post:
2021-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physiological Study to Compare Noninvasive Ventilation (NIV) Masks
Sponsor:
Fisher and Paykel Healthcare
Organization:
Study Overview
Official Title:
Physiological Study to Compare Noninvasive Ventilation (NIV) Masks
Status:
TERMINATED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Extremely slow recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
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).
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1259-4797 | REGISTRY | WHO Universal trial number | View |