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Humidification Needs

Primary Purpose

Obstructive Sleep Apnea

Status
Terminated
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Condition A: CPAP with No Humidification
Condition B: CPAP with No Humidification
Condition C: CPAP with Cold Passover
Condition D: CPAP with Modified humidifier
Condition E: CPAP with Ambient Tracking
Condition F: CPAP with Heated Humidification
Condition G: CPAP with Heated Humidification
Condition H: CPAP with New level humidification
Sponsored by
Fisher and Paykel Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Fisher and Paykel Healthcare

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Condition A: CPAP with No Humidification

Condition B: CPAP with No Humidification

Condition C: CPAP with Cold Passover humidifier

Condition D: CPAP with Modified Humidifier

Condition E: CPAP with Ambient Tracking

Condition F: CPAP with Heated Humidification

Condition G: CPAP with Heated Humidification

Condition H: CPAP with New level humidification

Arm Description

CPAP with No Humidification with no mouth leak

CPAP with No Humidification with mouth leak

CPAP with Cold Passover humidifier 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

Outcomes

Primary Outcome Measures

Nasal Resistance
Will be measured by rhinomanometer or acoustic rhinometry
Evaluation of Nasal Dryness and Discomfort
Reported by participants using the Xero Questionnaire

Secondary Outcome Measures

Preference of Testing Condition
Measured by custom preference questionnaire

Full Information

First Posted
August 7, 2017
Last Updated
April 17, 2019
Sponsor
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT03247907
Brief Title
Humidification Needs
Official Title
Humidification Needs
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Trial was terminated by investigators due to equipment difficulties
Study Start Date
October 9, 2017 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Condition A: CPAP with No Humidification
Arm Type
Active Comparator
Arm Description
CPAP with No Humidification with no mouth leak
Arm Title
Condition B: CPAP with No Humidification
Arm Type
Active Comparator
Arm Description
CPAP with No Humidification with mouth leak
Arm Title
Condition C: CPAP with Cold Passover humidifier
Arm Type
Active Comparator
Arm Description
CPAP with Cold Passover humidifier with mouth leak
Arm Title
Condition D: CPAP with Modified Humidifier
Arm Type
Active Comparator
Arm Description
CPAP with Modified Humidifier with mouth leak
Arm Title
Condition E: CPAP with Ambient Tracking
Arm Type
Active Comparator
Arm Description
CPAP with Ambient Tracking with mouth leak
Arm Title
Condition F: CPAP with Heated Humidification
Arm Type
Active Comparator
Arm Description
CPAP with Heated Humidification at default setting with mouth leak
Arm Title
Condition G: CPAP with Heated Humidification
Arm Type
Active Comparator
Arm Description
CPAP with Heated Humidification at max setting with mouth leak
Arm Title
Condition H: CPAP with New level humidification
Arm Type
Active Comparator
Arm Description
CPAP with New level humidification with mouth leak
Intervention Type
Device
Intervention Name(s)
Condition A: CPAP with No Humidification
Intervention Description
CPAP with No Humidification with no mouth leak
Intervention Type
Device
Intervention Name(s)
Condition B: CPAP with No Humidification
Intervention Description
CPAP with No Humidification with mouth leak
Intervention Type
Device
Intervention Name(s)
Condition C: CPAP with Cold Passover
Intervention Description
CPAP with Cold Passover with mouth leak
Intervention Type
Device
Intervention Name(s)
Condition D: CPAP with Modified humidifier
Intervention Description
CPAP with Modified humidifier with mouth leak
Intervention Type
Device
Intervention Name(s)
Condition E: CPAP with Ambient Tracking
Intervention Description
CPAP with Ambient Tracking with mouth leak
Intervention Type
Device
Intervention Name(s)
Condition F: CPAP with Heated Humidification
Intervention Description
CPAP with Heated Humidification at default setting with mouth leak
Intervention Type
Device
Intervention Name(s)
Condition G: CPAP with Heated Humidification
Intervention Description
CPAP with Heated Humidification at max setting with mouth leak
Intervention Type
Device
Intervention Name(s)
Condition H: CPAP with New level humidification
Intervention Description
CPAP with New level humidification with mouth leak
Primary Outcome Measure Information:
Title
Nasal Resistance
Description
Will be measured by rhinomanometer or acoustic rhinometry
Time Frame
8 Days
Title
Evaluation of Nasal Dryness and Discomfort
Description
Reported by participants using the Xero Questionnaire
Time Frame
8 Days
Secondary Outcome Measure Information:
Title
Preference of Testing Condition
Description
Measured by custom preference questionnaire
Time Frame
8 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Fisher and Paykel Healthcare
City
East Tamaki
State/Province
Auckland
ZIP/Postal Code
2013
Country
New Zealand

12. IPD Sharing Statement

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Humidification Needs

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