The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03247907




Registration number
NCT03247907
Ethics application status
Date submitted
7/08/2017
Date registered
14/08/2017
Date last updated
19/04/2019

Titles & IDs
Public title
Humidification Needs
Scientific title
Humidification Needs
Secondary ID [1] 0 0
CIA-191
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Condition A: CPAP with No Humidification
Treatment: Devices - Condition B: CPAP with No Humidification
Treatment: Devices - Condition C: CPAP with Cold Passover
Treatment: Devices - Condition D: CPAP with Modified humidifier
Treatment: Devices - Condition E: CPAP with Ambient Tracking
Treatment: Devices - Condition F: CPAP with Heated Humidification
Treatment: Devices - Condition G: CPAP with Heated Humidification
Treatment: Devices - Condition H: CPAP with New level humidification

Active Comparator: Condition A: CPAP with No Humidification - CPAP with No Humidification with no mouth leak

Active Comparator: Condition B: CPAP with No Humidification - CPAP with No Humidification with mouth leak

Active Comparator: Condition C: CPAP with Cold Passover humidifier - CPAP with Cold Passover humidifier with mouth leak

Active Comparator: Condition D: CPAP with Modified Humidifier - CPAP with Modified Humidifier with mouth leak

Active Comparator: Condition E: CPAP with Ambient Tracking - CPAP with Ambient Tracking with mouth leak

Active Comparator: Condition F: CPAP with Heated Humidification - CPAP with Heated Humidification at default setting with mouth leak

Active Comparator: Condition G: CPAP with Heated Humidification - CPAP with Heated Humidification at max setting with mouth leak

Active Comparator: Condition H: CPAP with New level humidification - CPAP with New level humidification with mouth leak


Treatment: Devices: Condition A: CPAP with No Humidification
CPAP with No Humidification with no mouth leak

Treatment: Devices: Condition B: CPAP with No Humidification
CPAP with No Humidification with mouth leak

Treatment: Devices: Condition C: CPAP with Cold Passover
CPAP with Cold Passover with mouth leak

Treatment: Devices: Condition D: CPAP with Modified humidifier
CPAP with Modified humidifier with mouth leak

Treatment: Devices: Condition E: CPAP with Ambient Tracking
CPAP with Ambient Tracking with mouth leak

Treatment: Devices: Condition F: CPAP with Heated Humidification
CPAP with Heated Humidification at default setting with mouth leak

Treatment: Devices: Condition G: CPAP with Heated Humidification
CPAP with Heated Humidification at max setting with mouth leak

Treatment: Devices: Condition H: CPAP with New level humidification
CPAP with New level humidification with mouth leak

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Nasal Resistance - Will be measured by rhinomanometer or acoustic rhinometry
Timepoint [1] 0 0
8 Days
Primary outcome [2] 0 0
Evaluation of Nasal Dryness and Discomfort - Reported by participants using the Xero Questionnaire
Timepoint [2] 0 0
8 Days
Secondary outcome [1] 0 0
Preference of Testing Condition - Measured by custom preference questionnaire
Timepoint [1] 0 0
8 Days

Eligibility
Key inclusion criteria
- Aged 18 and over
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Inability to give consent

- Currently pregnant or think they may be pregnant

- Current nasal symptoms or chronic nasal disease

- Contraindicated for PAP therapy

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A study undertaken to investigate mouth leak for airway discomfort/dryness while using CPAP.
This study will also measure how much humidification is required to treat subsequent upper
airway discomfort/dryness from mouth leak by utilizing different levels and types of
humidification.
Trial website
https://clinicaltrials.gov/show/NCT03247907
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03247907