Humidification Needs

Fisher & Paykel Healthcare

Status: Terminated

Conditions: Obstructive Sleep Apnea

Treatments: Device: Condition A: CPAP with No Humidification; Device: Condition G: CPAP with Heated Humidification; Device: Condition B: CPAP with No Humidification; Device: Condition C: CPAP with Cold Passover; Device: Condition H: CPAP with New level humidification; Device: Condition E: CPAP with Ambient Tracking; Device: Condition D: CPAP with Modified humidifier; Device: Condition F: CPAP with Heated Humidification

Study type: Interventional

Funder types: Industry

Identifiers

NCT03247907

CIA-191

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 8 patient groups

Condition A: CPAP with No Humidification

Active Comparator group

Description:

CPAP with No Humidification with no mouth leak

Treatment:

Device: Condition A: CPAP with No Humidification

Condition B: CPAP with No Humidification

Active Comparator group

Description:

CPAP with No Humidification with mouth leak

Treatment:

Device: Condition B: CPAP with No Humidification

Condition C: CPAP with Cold Passover humidifier

Active Comparator group

Description:

CPAP with Cold Passover humidifier with mouth leak

Treatment:

Device: Condition C: CPAP with Cold Passover

Condition D: CPAP with Modified Humidifier

Active Comparator group

Description:

CPAP with Modified Humidifier with mouth leak

Treatment:

Device: Condition D: CPAP with Modified humidifier

Condition E: CPAP with Ambient Tracking

Active Comparator group

Description:

CPAP with Ambient Tracking with mouth leak

Treatment:

Device: Condition E: CPAP with Ambient Tracking

Condition F: CPAP with Heated Humidification

Active Comparator group

Description:

CPAP with Heated Humidification at default setting with mouth leak

Treatment:

Device: Condition F: CPAP with Heated Humidification

Condition G: CPAP with Heated Humidification

Active Comparator group

Description:

CPAP with Heated Humidification at max setting with mouth leak

Treatment:

Device: Condition G: CPAP with Heated Humidification

Condition H: CPAP with New level humidification

Active Comparator group

Description:

CPAP with New level humidification with mouth leak

Treatment:

Device: Condition H: CPAP with New level humidification