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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Timepoint [1] 0 0
8 Days
Primary outcome [2] 0 0
Evaluation of Nasal Dryness and Discomfort
Timepoint [2] 0 0
8 Days
Secondary outcome [1] 0 0
Preference of Testing Condition
Timepoint [1] 0 0
8 Days

Eligibility
Key inclusion criteria
- Aged 18 and over
Minimum age
18 Years
Maximum age
No limit
Sex
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
9/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2018
Sample size
Target
Accrual to date
Final
10
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/ct2/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/ct2/show/NCT03247907