Humidification Needs

April 17, 2019 updated by: Fisher and Paykel Healthcare
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
    • Auckland
      • East Tamaki, Auckland, New Zealand, 2013
        • Fisher and Paykel Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Condition A: CPAP with No Humidification
CPAP with No Humidification with no mouth leak
Device: 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
Device: 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
Device: Condition C: CPAP with Cold Passover
CPAP with Cold Passover with mouth leak
Active Comparator: Condition D: CPAP with Modified Humidifier
CPAP with Modified Humidifier with mouth leak
Device: 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
Device: 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
Device: 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
Device: 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
Device: Condition H: CPAP with New level humidification
CPAP with New level humidification with mouth leak

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal Resistance
Time Frame: 8 Days
Will be measured by rhinomanometer or acoustic rhinometry
8 Days
Evaluation of Nasal Dryness and Discomfort
Time Frame: 8 Days
Reported by participants using the Xero Questionnaire
8 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preference of Testing Condition
Time Frame: 8 Days
Measured by custom preference questionnaire
8 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fisher and Paykel Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2017

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

August 7, 2017

First Submitted That Met QC Criteria

August 9, 2017

First Posted (Actual)

August 14, 2017

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIA-191

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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