NCT04926805

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 15, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

July 7, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2023

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

1.3 years

First QC Date

June 2, 2021

Last Update Submit

July 10, 2023

Conditions

Sleep-disordered BreathingHypercapnia

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

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

CPAP with Mask ADEVICE

CPAP mask

Mask A
CPAP with Mask BDEVICE

CPAP mask

Mask B

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Zealand Respiratory and Sleep Institute

Auckland, 1051, New Zealand

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesHypercapnia

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Andy Veale, Dr

    New Zealand Respiratory and Sleep Insitute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 15, 2021

Study Start

July 7, 2021

Primary Completion

October 14, 2022

Study Completion

July 5, 2023

Last Updated

July 12, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

NZ(1)