Study Stopped
Trial was terminated by investigators due to equipment difficulties
Humidification Needs
1 other identifier
interventional
10
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2017
1 active site
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
August 7, 2017
CompletedFirst Posted
Study publicly available on registry
August 14, 2017
CompletedStudy Start
First participant enrolled
October 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedApril 19, 2019
April 1, 2019
12 months
August 7, 2017
April 17, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Nasal Resistance
Will be measured by rhinomanometer or acoustic rhinometry
8 Days
Evaluation of Nasal Dryness and Discomfort
Reported by participants using the Xero Questionnaire
8 Days
Secondary Outcomes (1)
Preference of Testing Condition
8 Days
Study Arms (8)
Condition A: CPAP with No Humidification
ACTIVE COMPARATORCPAP with No Humidification with no mouth leak
Condition B: CPAP with No Humidification
ACTIVE COMPARATORCPAP with No Humidification with mouth leak
Condition C: CPAP with Cold Passover humidifier
ACTIVE COMPARATORCPAP with Cold Passover humidifier with mouth leak
Condition D: CPAP with Modified Humidifier
ACTIVE COMPARATORCPAP with Modified Humidifier with mouth leak
Condition E: CPAP with Ambient Tracking
ACTIVE COMPARATORCPAP with Ambient Tracking with mouth leak
Condition F: CPAP with Heated Humidification
ACTIVE COMPARATORCPAP with Heated Humidification at default setting with mouth leak
Condition G: CPAP with Heated Humidification
ACTIVE COMPARATORCPAP with Heated Humidification at max setting with mouth leak
Condition H: CPAP with New level humidification
ACTIVE COMPARATORCPAP with New level humidification with mouth leak
Interventions
CPAP with No Humidification with no mouth leak
CPAP with No Humidification with mouth leak
CPAP with Cold Passover with mouth leak
CPAP with Modified humidifier with mouth leak
CPAP with Ambient Tracking with mouth leak
CPAP with Heated Humidification at default setting with mouth leak
CPAP with Heated Humidification at max setting with mouth leak
CPAP with New level humidification with mouth leak
Eligibility Criteria
You may qualify if:
- Aged 18 and over
You may not qualify if:
- Inability to give consent
- Currently pregnant or think they may be pregnant
- Current nasal symptoms or chronic nasal disease
- Contraindicated for PAP therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fisher and Paykel Healthcare
East Tamaki, Auckland, 2013, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2017
First Posted
August 14, 2017
Study Start
October 9, 2017
Primary Completion
September 30, 2018
Study Completion
September 30, 2018
Last Updated
April 19, 2019
Record last verified: 2019-04