Humidification Needs

NCT ID: NCT03247907

Last Updated: 2019-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-09

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Condition A: CPAP with No Humidification

CPAP with No Humidification with no mouth leak

Group Type ACTIVE_COMPARATOR

Condition A: CPAP with No Humidification

Intervention Type DEVICE

CPAP with No Humidification with no mouth leak

Condition B: CPAP with No Humidification

CPAP with No Humidification with mouth leak

Group Type ACTIVE_COMPARATOR

Condition B: CPAP with No Humidification

Intervention Type DEVICE

CPAP with No Humidification with mouth leak

Condition C: CPAP with Cold Passover humidifier

CPAP with Cold Passover humidifier with mouth leak

Group Type ACTIVE_COMPARATOR

Condition C: CPAP with Cold Passover

Intervention Type DEVICE

CPAP with Cold Passover with mouth leak

Condition D: CPAP with Modified Humidifier

CPAP with Modified Humidifier with mouth leak

Group Type ACTIVE_COMPARATOR

Condition D: CPAP with Modified humidifier

Intervention Type DEVICE

CPAP with Modified humidifier with mouth leak

Condition E: CPAP with Ambient Tracking

CPAP with Ambient Tracking with mouth leak

Group Type ACTIVE_COMPARATOR

Condition E: CPAP with Ambient Tracking

Intervention Type DEVICE

CPAP with Ambient Tracking with mouth leak

Condition F: CPAP with Heated Humidification

CPAP with Heated Humidification at default setting with mouth leak

Group Type ACTIVE_COMPARATOR

Condition F: CPAP with Heated Humidification

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

Condition G: CPAP with Heated Humidification

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

Condition H: CPAP with New level humidification

Intervention Type DEVICE

CPAP with New level humidification with mouth leak

Interventions

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Condition A: CPAP with No Humidification

CPAP with No Humidification with no mouth leak

Intervention Type DEVICE

Condition B: CPAP with No Humidification

CPAP with No Humidification with mouth leak

Intervention Type DEVICE

Condition C: CPAP with Cold Passover

CPAP with Cold Passover with mouth leak

Intervention Type DEVICE

Condition D: CPAP with Modified humidifier

CPAP with Modified humidifier with mouth leak

Intervention Type DEVICE

Condition E: CPAP with Ambient Tracking

CPAP with Ambient Tracking with mouth leak

Intervention Type DEVICE

Condition F: CPAP with Heated Humidification

CPAP with Heated Humidification at default setting with mouth leak

Intervention Type DEVICE

Condition G: CPAP with Heated Humidification

CPAP with Heated Humidification at max setting with mouth leak

Intervention Type DEVICE

Condition H: CPAP with New level humidification

CPAP with New level humidification with mouth leak

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fisher and Paykel Healthcare

East Tamaki, Auckland, New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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CIA-191

Identifier Type: -

Identifier Source: org_study_id

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