NCT02473068

Brief Summary

Patients who are suffering from a variety of respiratory conditions benefit from continuous positive airway pressure (CPAP) which is a form of Non-Invasive Ventilation (NIV). Some patients find the temperature of the breathing gas difficult to tolerate. The aim of this study is to compare comfort of healthy volunteer participants while being given CPAP at different temperatures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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 12, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

June 19, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2019

Completed
Last Updated

July 5, 2019

Status Verified

June 1, 2019

Enrollment Period

1 year

First QC Date

June 12, 2015

Last Update Submit

July 1, 2019

Conditions

Healthy

Keywords

CPAP

Outcome Measures

Primary Outcomes (1)

  • Participant Comfort Questionnaire

    Participant answers questions to indicate comfort

    30 Minutes

Study Arms (2)

Group 1

ACTIVE COMPARATOR

In random order, CPAP via a standard humidifier with chamber output temperature of 31°C, or CPAP with a prototype humidifier with chamber output temperature of 31°C.

Device: CPAP

Group 2

EXPERIMENTAL

In random order, CPAP via a standard humidifier with chamber output temperature of 31°C, or CPAP with a prototype humidifier with chamber output temperature of 27°C.

Device: CPAP

Interventions

CPAPDEVICE
Group 1Group 2

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any employee of FPH willing to take part in the study following review of the Participant Information Sheet and who has provided affirmative answers to the questions / statements included on the Consent Form

You may not qualify if:

  • Any employee of FPH not willing to take part in the study following review of the Participant Information Sheet.
  • Any employee of FPH who has not provided affirmative answers to the questions / statements included on the Consent Form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fisher and Paykel Healthcare

Auckland, 2013, New Zealand

Location

Study Officials

  • Geoff Bold, PhD

    Fisher & Paykel Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2015

First Posted

June 16, 2015

Study Start

June 19, 2015

Primary Completion

July 1, 2016

Study Completion

June 4, 2019

Last Updated

July 5, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

NZ(1)