Humidification Needs

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03247907

Enrollment

Registered

2017-08-14

Start date

2017-10-09

Completion date

2018-09-30

Last updated

2019-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

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.

Interventions

DEVICECondition A: CPAP with No Humidification

CPAP with No Humidification with no mouth leak

DEVICECondition B: CPAP with No Humidification

CPAP with No Humidification with mouth leak

DEVICECondition C: CPAP with Cold Passover

CPAP with Cold Passover with mouth leak

DEVICECondition D: CPAP with Modified humidifier

CPAP with Modified humidifier with mouth leak

DEVICECondition E: CPAP with Ambient Tracking

CPAP with Ambient Tracking with mouth leak

DEVICECondition F: CPAP with Heated Humidification

CPAP with Heated Humidification at default setting with mouth leak

DEVICECondition G: CPAP with Heated Humidification

CPAP with Heated Humidification at max setting with mouth leak

DEVICECondition H: CPAP with New level humidification

CPAP with New level humidification with mouth leak

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Preference of Testing Condition	8 Days	Measured by custom preference questionnaire

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026