Pilairo Lab Market Research

Obstructive Sleep Apnea Clinical Trial

Official title:

Pilairo Lab Market Research

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824979
• Other study ID #: CIA76
• Status: Completed
• Phase: N/A
• First received: April 2, 2013
• Last updated: February 8, 2018
• Start date: December 2012
• Est. completion date: May 2013

Study information

• Verified date: February 2018
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP mask ( Pilairo)

Procedure:
• Other CPAP mask

Locations

Country	Name	City	State
United States	Peninsula Sleep Center Inc	Burlingame	California

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technician Experience With Mask	Measured from a single item, sleep technicians indicated their experience using the Pilairo or Other CPAP mask during the CPAP titration. Response options ranged on a scale from 0 to 10 with 0 indicating an extremely poor experience and 10 indicating and extremely pleasant experience.	One night
Secondary	Number of Mask Interventions During the Night	Sleep technicians reported the number of times they had to intervene with the mask to get a good seal or improve comfort.	One night