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NCT03247907 Clinical Trial

Humidification Needs

Obstructive Sleep Apnea Clinical Trial

Official title:
Humidification Needs

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03247907
Other study ID # CIA-191
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 9, 2017
Est. completion date September 30, 2018

Study information
Verified date April 2019
Source Fisher and Paykel Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 10
Est. completion date September 30, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Aged 18 and over

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

Related Conditions & MeSH terms

Intervention

Device:
• Condition A: CPAP with No Humidification
CPAP with No Humidification with no mouth leak
• Condition B: CPAP with No Humidification
CPAP with No Humidification with mouth leak
• Condition C: CPAP with Cold Passover
CPAP with Cold Passover with mouth leak
• Condition D: CPAP with Modified humidifier
CPAP with Modified humidifier with mouth leak
• Condition E: CPAP with Ambient Tracking
CPAP with Ambient Tracking with mouth leak
• Condition F: CPAP with Heated Humidification
CPAP with Heated Humidification at default setting with mouth leak
• Condition G: CPAP with Heated Humidification
CPAP with Heated Humidification at max setting with mouth leak
• Condition H: CPAP with New level humidification
CPAP with New level humidification with mouth leak

Locations
Country Name City State
New Zealand Fisher and Paykel Healthcare East Tamaki Auckland

Sponsors (1)
Lead Sponsor Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

New Zealand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Nasal Resistance Will be measured by rhinomanometer or acoustic rhinometry 8 Days
Primary Evaluation of Nasal Dryness and Discomfort Reported by participants using the Xero Questionnaire 8 Days
Secondary Preference of Testing Condition Measured by custom preference questionnaire 8 Days
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