Pilairo Lab Market Research

Fisher & Paykel Healthcare

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: CPAP mask ( Pilairo); Procedure: Other CPAP mask

Study type: Interventional

Funder types: Industry

Identifiers

NCT01824979

CIA76

Details and patient eligibility

About

The purpose of the study is to observe the Pilairo mask in a lab setting.

Full description

The purpose of the study is to observe the Pilairo mask in a lab setting, compared to other commercially available masks for continuous positive airwary pressure (CPAP) therapy.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Apnea Hypopnea Indea >15 from diagnostic study
• Minimum 18 years of age

Exclusion criteria

• Inability ot give informed consent
• History of intolerance to CPAP
• Anatomical or physiological conditions making CPAP therapy inappropriate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Pilairo mask

Experimental group

Description:

Pilairo nasal pillows mask during CPAP titration

Treatment:

Device: CPAP mask ( Pilairo)

Other CPAP mask

Active Comparator group

Description:

Other CPAP mask during CPAP titration

Treatment:

Procedure: Other CPAP mask